Systems for treating a hollow anatomical structure

ABSTRACT

A working end of a catheter includes at least one therapeutic element, such as a resistive heating element, usable to deliver energy for ligating, or reducing the diameter of, a hollow anatomical structure. In certain examples, the catheter includes a lumen to accommodate a guide wire or to allow fluid delivery. In certain embodiments, a balloon is inflated to place resistive element(s) into apposition with a hollow anatomical structure and to occlude the structure. Indexing devices and methods are also disclosed for successively treating portions of the hollow anatomical structure. In certain examples, marks along the catheter shaft provide visual verification to the physician of the relative position of the therapeutic element of the catheter. Embodiments of indexing devices may include pairs of rings and/or hinged arms that move a catheter a desired indexed position between successive treatments.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/686,323, filed Jan. 12, 2010, entitled “SYSTEMS FOR TREATING A HOLLOWANATOMICAL STRUCTURE” which is a continuation of U.S. application Ser.No. 11/491,348, filed Jul. 21, 2006, entitled “SYSTEMS AND METHODS FORTREATING A HOLLOW ANATOMICAL STRUCTURE” which claims the benefit ofpriority under 35 U.S.C. §119(e) of each of U.S. Provisional ApplicationNo. 60/780,948, filed Mar. 9, 2006, entitled “SYSTEMS AND METHODS FORTREATING A HOLLOW ANATOMICAL STRUCTURE,” and U.S. ProvisionalApplication No. 60/701,303, filed Jul. 21, 2005, entitled “RESISTIVEELEMENT SYSTEM,” all of which are hereby incorporated herein byreference in their entirety and are to be considered a part of thisspecification.

BACKGROUND

1. Field

Certain disclosed embodiments relate to methods and apparatus forapplying energy to constrict and/or shrink a hollow anatomicalstructure, such as a vein.

2. Description of the Related Art

The human venous system of the lower extremities consists essentially ofthe superficial venous system and the deep venous system withperforating veins connecting the two systems. The superficial systemincludes the long or great saphenous vein and the small saphenous vein.The deep venous system includes the anterior and posterior tibial veinswhich unite to form the popliteal vein, which in turn becomes thefemoral vein when joined by the short saphenous vein.

The venous system contains numerous one-way valves for directing bloodflow back to the heart. Venous valves are usually bicuspid valves, witheach cusp forming a sack or reservoir for blood. Retrograde blood flowforces the free surfaces of the cusps together to prevent continuedretrograde flow of the blood and allows only antegrade blood flow to theheart. When an incompetent valve is in the flow path, the valve isunable to close because the cusps do not form a proper seal, andretrograde flow of the blood cannot be stopped. When a venous valvefails, increased strain and pressure occur within the lower venoussections and overlying tissues, sometimes leading to additional,limb-distal valvular failure. Two venous conditions or symptoms whichoften result from valve failure are varicose veins and more symptomaticchronic venous insufficiency.

SUMMARY

Disclosed herein are systems and methods for ligating and/orsubstantially occluding a hollow anatomical structure (HAS), such as,for example, a vein. In particular, certain disclosed embodimentsinclude devices having a therapeutic element, such as a resistiveheating element, that is capable of directly applying energy to theinner wall of the hollow anatomical structure. In certain embodiments,this application of energy causes collagen denaturation and shrinkagesuch that the HAS diameter is substantially reduced and the HAS wallbecomes thickened such that the end result is generally a HAS “lumen”filled with fibrin whereas fluid can no longer flow therethrough. Alsodisclosed are indexing methods and devices that facilitate treatment ofsuccessive portions of the hollow anatomical structure.

One embodiment comprises a catheter for use in treating a hollowanatomical structure. The catheter comprises an elongated shaft having adistal end and a proximal end; and an energy application device locatedproximate the distal end of the shaft. The energy application device hasa first length. The catheter further comprises a plurality of indexmarkers located along the shaft and proximal of the energy applicationdevice such that consecutive index markers are spaced apart by a secondlength. The second length comprises an indexing distance of the energyapplication device.

In one variation of the catheter, the second length is approximatelyequal to or slightly shorter than the first length. In a furthervariation, the first length is between approximately 2 centimeters andapproximately 10 centimeters and the second length is betweenapproximately 0.1 centimeter and approximately 1.5 centimeters less thanthe first length. In another further variation, the first length isapproximately 7 centimeters and the second length is approximately 6.5centimeters.

In some variations of the catheter, the shaft further comprises astop-treatment marker or a last-treatment marker located proximal of theenergy application device and distal of the plurality of index markers.In a further variation, the stop-treatment marker can include aplurality of warning markers corresponding to a plurality of introducerlengths.

In some variations of the catheter, the plurality of index markers cancomprise any of the following: alphanumeric markers, color-codedmarkers, geometrically coded markers, at least one magnetic ink markerreadable by an external sensor, or at least one detent in the shaft.

In one variation of the catheter, at least a portion of the catheter issterile. In a further variation, a method can comprise sterilizing thecatheter.

In some variations of the catheter, the energy application device canhave an adjustable active length, and/or an active region which isadjustable in size. In a further variation, the energy applicationdevice comprises a heater element with a plurality of separatelyoperable heater sections which are arranged longitudinally along thefirst length.

Another embodiment comprises a method for treating a hollow anatomicalstructure. The method comprises inserting a catheter having an energyapplication device having a first length and indexing marks on thecatheter shaft proximal to the energy application device through anintroducer sheath in a hollow anatomical structure of a patient. Themethod further comprises positioning the energy application device at afirst treatment location in the hollow anatomical structure. The methodfurther comprises, while the energy application device is at the firsttreatment location of the hollow anatomical structure, withdrawing thesheath or adjusting a reference point of the sheath until the referencepoint of the sheath is aligned with one of the indexing marks on thecatheter shaft. The method further comprises applying energy with theenergy application device to the first treatment location in the hollowanatomical structure; and positioning the catheter at one or moresubsequent treatment locations in the hollow anatomical structure bymoving the catheter shaft through the sheath until another one or moreof the indexing marks is aligned with the reference point of the sheath.The method further comprises applying energy with the energy applicationdevice to each subsequent treatment location.

In some variations of the method, the reference point of the sheathcomprises the proximal end of the sheath, or an adjustable referencemarker.

In one variation, the method further comprises securing the sheath withrespect to the hollow anatomical structure before moving the catheter toone or more subsequent treatment locations. Securing the sheath canoptionally comprise securing the sheath to the patient.

Another embodiment comprises a method for treating a hollow anatomicalstructure. The method comprises inserting a catheter into a hollowanatomical structure of a patient. The catheter has an energyapplication device with a first length. The method further comprisesapplying energy, with the energy application device, to a firsttreatment location of the hollow anatomical structure. The methodfurther comprises moving the catheter proximally to one or moreadditional treatment locations of the hollow anatomical structure,wherein each additional treatment location is offset by an indexinglength from the preceding treatment location. The method furthercomprises applying energy, with the energy application device, to theone or more additional treatment locations of the hollow anatomicalstructure.

In one variation of the method, the indexing length is approximatelyequal to or slightly shorter than the first length.

In another variation of the method, moving the catheter proximallycomprises aligning an index marking on the catheter with a referencepoint. The reference point can optionally be on an introducer throughwhich the catheter is inserted.

Another variation of the method further comprises monitoring atemperature within the hollow anatomical structure.

In some variations of the method, applying energy to the first locationcan comprise applying energy to the first location at two distincttimes, or applying energy to the first location for a longer durationthan to any one of the additional locations. Where energy is applied tothe first location for a longer duration, the hollow anatomicalstructure can optionally have a larger cross-sectional profile, asviewed along a longitudinal axis of the hollow anatomical structure, inthe first location than in any of the additional locations. Where energyis applied to the first location for a longer duration, the hollowanatomical structure can comprise the great saphenous vein, and thefirst location can be closer to the sapheno-femoral junction than is anyof the additional locations.

Another embodiment comprises an apparatus. The apparatus comprises acatheter shaft extending from a proximal end to a distal end; an energyapplication device proximate the distal end of the catheter shaft; andmarkers along the length of the catheter shaft. The markers are spacedapart at a multiple of the length of the energy application device.

In one variation of the apparatus, the length of the energy applicationdevice is between approximately 2 centimeters and approximately 10centimeters.

In another variation of the apparatus, the energy application device isa resistive heating device. Such an energy application device canoptionally be a wound nichrome wire.

In another variation of the apparatus, the energy application devicecomprises a Resistance Temperature Detector (RTD) configured to sensethe temperature of the energy application device by a measurement of theimpedance of the energy application device.

In another variation of the apparatus, the energy application devicecomprises one or more radio frequency (RF) electrodes.

In another variation of the apparatus, the markers are spaced apart at afraction of the length of the energy application device.

In another variation of the apparatus, at least a portion of theapparatus is sterile. A method can comprise sterilizing the apparatus.

Another variation of the apparatus further comprises at least onetemperature sensor.

In another variation of the apparatus, the energy application device hasan adjustable active length.

In another variation of the apparatus, the energy application device hasan active region which is adjustable in size. Such an energy applicationdevice can optionally comprise a heater element with a plurality ofseparately operable heater sections which are arranged longitudinally.

Another embodiment comprises a method for treating a hollow anatomicalstructure. The method comprises inserting a catheter having a heatingelement coupled thereto, into a hollow anatomical structure; energizingthe heating element at a first treatment position within the hollowanatomical structure; moving the catheter an indexed distance in aproximal direction to an additional treatment position within the hollowanatomical structure; and energizing the heating element at theadditional treatment position.

In one variation of the method, the method further comprises repeating(a) moving the catheter an indexed distance to an additional treatmentposition, and (b) energizing the heating element at the additionaltreatment position, until a desired length of the hollow anatomicalstructure is treated.

In another variation of the method, the hollow anatomical structurecomprises a human vein.

Another variation of the method further comprises determining theindexed distance with a plurality of markings along a shaft of thecatheter.

In another variation of the method, moving the catheter the indexeddistance comprises securing a proximal end of an indexing device to ashaft of the catheter; and extending the proximal end of the indexingdevice the indexed distance from a distal end of the indexing device,thereby moving the catheter shaft by the indexed distance from thedistal end of the indexing device.

In another variation of the method, at least one of the additionaltreatment locations slightly overlaps the preceding treatment location.

In another variation of the method, energizing the heating element atthe first treatment position comprises energizing the heating element attwo distinct times.

In another variation of the method, energizing the heating element atthe first treatment position comprises energizing the heating elementfor a longer duration than at any one of the additional treatmentpositions. In this variation, the hollow anatomical structure canoptionally have a larger cross-sectional profile, as viewed along alongitudinal axis of the hollow anatomical structure, in the firsttreatment position than in any of the additional treatment positions. Inthis variation, the hollow anatomical structure can further optionallycomprise the great saphenous vein, and the first treatment position canbe closer to the sapheno-femoral junction than is any of the additionaltreatment positions.

Another embodiment comprises a catheter for treating a hollow anatomicalstructure. The catheter comprises an elongate shaft; means for applyingenergy to a hollow anatomical structure. The means for applying energyis secured to the shaft and has a first length. The catheter furthercomprises a plurality of means for indexing located along the shaft andproximal of the means for applying energy. Each of the plurality ofmeans for indexing is spaced apart by a second length.

In one variation of the catheter, the second length is approximatelyequal to or slightly less than the first length.

In another variation of the catheter, the means for applying energycomprises a resistive heating device.

Another embodiment comprises a catheter for use in treating a hollowanatomical structure. The catheter comprises an elongated shaft having adistal end and a proximal end; and an energy application device coupledto the shaft. The energy application device has a first length. Thecatheter further comprises a plurality of index markers located alongthe shaft and proximal of the energy application device such thatconsecutive index markers are spaced apart by a second length. Thesecond length is equal to the first length less a decrement. Thedecrement is between 1% and 15% of the first length.

In one variation of the catheter, the first length is between 2 and 10centimeters, and the decrement is between 0.1 and 1.5 centimeters.

In another variation of the catheter, the first length is approximately7 centimeters and the second length is approximately 6.5 centimeters.

In another variation of the catheter, the shaft further comprises astop-treatment marker located distal of the plurality of index markers,and the stop-treatment marker is distinct from the index markers.

In another variation of the catheter, the energy application devicecomprises an electrically driven heater element.

In another variation of the catheter, the energy application device hasan energy coupling surface which extends along the first length. In sucha variation, the first length can be at least ten times a width of theenergy application device.

In another variation of the catheter, the energy application device isconfigured to generate heat internally and transfer heat radiallyoutwardly away from a central longitudinal axis of the energyapplication device.

Another embodiment comprises an introducer sheath. The introducer sheathcomprises a sheath lumen having a distal end which is insertable into ahollow anatomical structure. The sheath lumen extends generally along aluminal axis in a distal-to-proximal direction. The introducer sheathfurther comprises an adjustable reference marker connected to thesheath. The longitudinal position, as measured along the luminal axis,of the reference marker is adjustable.

In one variation of the introducer sheath, the adjustable referencemarker includes a flexible elongate member of variable length that isattached to the proximal end of the sheath.

In another variation of the introducer sheath, the adjustable referencemarker is removably connected to the sheath.

Another embodiment comprises a hollow anatomical structure treatmentsystem, which comprises the introducer sheath, and a catheter shaftdisposed in the sheath lumen. The catheter shaft extends proximally pastthe reference marker, and has a plurality of indexing marks. Thereference marker is longitudinally adjustable relative to the cathetershaft to permit alignment of the reference marker with one of theindexing marks without need for movement of the shaft relative to thesheath.

Another embodiment comprises a method of facilitating the treatment of ahollow anatomical structure. The method comprises initiating powerdelivery to an energy application device of a hollow anatomicalstructure treatment device; and measuring an operating parameter of thetreatment device. The operating parameter is relevant to energy couplingbetween the energy application device and its surroundings. The methodfurther comprises determining whether the operating parameter satisfiesa first energy coupling condition within a first time interval followingthe initiating; and, if the operating parameter does not satisfy thefirst energy coupling condition within the first time interval,providing a warning.

In one variation of the method, the operating parameter is a measure ofthe temperature of at least a portion of the treatment device. In such avariation, the operating parameter can optionally be a measure of thetemperature of at least a portion of the energy application device.

In another variation of the method, the operating parameter is a measureof the power delivered to the energy application device.

In another variation of the method, the power delivery is provided viaan electric current in the energy application device. In such avariation, the operating parameter can optionally be one of thefollowing: a measure of the electrical power delivered to the energyapplication device; a measure of the electric current; and/or a measureof the electrical impedance of the energy application device. In such avariation, the energy application device can optionally comprise aconducting coil.

In another variation of the method, the operating parameter is a measureof the temperature of at least a portion of the energy applicationdevice, and the first energy coupling condition comprises meeting orexceeding a first target temperature value for the temperature of atleast a portion of the energy application device. In such a variation,the first energy coupling condition can optionally comprise meeting orexceeding the first target temperature value within a prescribed periodof time after initiating power delivery.

In another variation of the method, the operating parameter is a measureof the temperature of at least a portion of the energy applicationdevice, and the first energy coupling condition comprises absence ofsudden changes to the temperature of at least a portion of the energyapplication device.

In another variation of the method, the operating parameter is a measureof the power delivered to the energy application device, and the firstenergy coupling condition comprises a delivered power magnitude which issubstantially similar to a reference waveform of expected powermagnitude.

In another variation of the method, the operating parameter is a measureof the power delivered to the energy application device, and the firstenergy coupling condition comprises a rate of change of the magnitude ofpower delivered to the energy application device which is substantiallysimilar to a reference waveform of expected power delivered afterachievement of a target temperature value.

In another variation of the method, the power delivery is provided viaan electric current in the energy application device, the operatingparameter is a measure of the electric current, and the first energycoupling condition comprises a delivered electric current magnitudewhich is substantially similar to a reference waveform of expectedelectric current magnitude.

In another variation of the method, the power delivery is provided viaan electric current in the energy application device, the operatingparameter is a measure of the electric current, and the first energycoupling condition comprises a rate of change of the magnitude ofelectric current delivered to the energy application device which issubstantially similar to a reference waveform of expected electriccurrent delivered after achievement of a target temperature value.

In another variation of the method, the power delivery is provided viaan electric current in the energy application device, the operatingparameter is a measure of the electrical impedance of the energyapplication device, and the first energy coupling condition comprises ameasured electrical impedance magnitude which is substantially similarto a reference waveform of expected electrical impedance of the energyapplication device.

In another variation of the method, the power delivery is provided viaan electric current in the energy application device, the operatingparameter is a measure of the electrical impedance of the energyapplication device, and the first energy coupling condition comprises ameasured rate of change of the magnitude of the electrical impedance ofthe energy application device which is substantially similar to areference waveform of expected electrical impedance of the energyapplication device.

Another variation of the method further comprises terminating orreducing power delivery to the energy application device if theoperating parameter does not satisfy the first energy coupling conditionwithin the first time interval.

In another variation of the method, the warning comprises a message toadjust the environment of the hollow anatomical structure treatmentdevice within a patient. In such a variation, the message instructs auser to adjust or improve compression of the portion of the hollowanatomical structure containing the treatment device.

Another variation of the method further comprises determining whetherthe operating parameter satisfies a second energy coupling conditionwithin a second time interval following the first time interval; and, ifthe operating parameter does not satisfy the second energy couplingcondition within the second time interval, providing a warning. In sucha variation, the method can optionally further comprise terminating orreducing power delivery to the energy application device if theoperating parameter does not satisfy the second energy couplingcondition within the second time interval.

Another embodiment comprises a method of facilitating the treatment of ahollow anatomical structure. The method comprises initiating powerdelivery to an energy application device of a hollow anatomicalstructure treatment device; measuring two operating parameters of thetreatment device, the operating parameters being relevant to energycoupling between the energy application device and its surroundings;determining whether the operating parameters satisfy a first energycoupling condition within a first time interval following theinitiating; and, if the operating parameters do not satisfy the firstenergy coupling condition within the first time interval, providing awarning.

In some variations of the method, the operating parameters are thetemperature of at least a portion of the energy application device andthe electrical impedance of the energy application device. In such avariation, the energy application device can optionally comprise aresistance temperature device; and the method can further optionallycomprise computing a temperature of the energy application device basedon the electrical impedance of the energy application device, and thefirst energy coupling condition can further optionally comprisecorrelation of the measured temperature of the energy application deviceto the computed temperature of the energy application device.

Another embodiment comprises an apparatus for use in treating a hollowanatomical structure. The apparatus comprises an energy applicationdevice adapted to receive power from a power source, and a measuringdevice that measures an operating parameter of the energy applicationdevice. The operating parameter is relevant to energy coupling betweenthe energy application device and its surroundings. The apparatusfurther comprises a module in communication with the measuring device.The module is configured to determine whether the operating parametersatisfies a first energy coupling condition within a first time intervalfollowing the initiation of power delivery to the energy applicationdevice. The apparatus further comprises a warning device incommunication with the module. The module is further configured to causethe warning device to provide a warning if the operating parameter doesnot satisfy the first energy coupling condition within the first timeinterval.

In one variation of the apparatus, the operating parameter is a measureof the temperature of at least a portion of the energy applicationdevice.

In another variation of the apparatus, the operating parameter is ameasure of the power delivered to the energy application device.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current. In such a variation,the operating parameter can optionally be any of the following: ameasure of the electrical power delivered to the energy applicationdevice; a measure of the electric current; and/or a measure of theelectrical impedance of the energy application device.

In another variation of the apparatus, the energy application devicecomprises a conducting coil.

In another variation of the apparatus, the operating parameter is ameasure of the temperature of at least a portion of the energyapplication device, and the first energy coupling condition comprisesmeeting or exceeding a first target temperature value for thetemperature of at least a portion of the energy application device. Insuch a variation, the first energy coupling condition can optionallycomprise meeting or exceeding the first target temperature value withina prescribed period of time after initiating power delivery.

In another variation of the apparatus, the operating parameter is ameasure of the temperature of at least a portion of the energyapplication device, and the first energy coupling condition comprisesabsence of sudden changes to the temperature of at least a portion ofthe energy application device.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, and the first energycoupling condition comprises a delivered power magnitude which issubstantially similar to a reference waveform of expected powermagnitude.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, and the first energycoupling condition comprises a rate of change of the magnitude of powerdelivered to the energy application device which is substantiallysimilar to a reference waveform of expected power delivered afterachievement of a target temperature value.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, the operatingparameter is a measure of the electric current, and the first energycoupling condition comprises a delivered electric current magnitudewhich is substantially similar to a reference waveform of expectedelectric current magnitude.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, the operatingparameter is a measure of the electric current, and the first energycoupling condition comprises a rate of change of the magnitude ofelectric current delivered to the energy application device which issubstantially similar to a reference waveform of expected electriccurrent delivered after achievement of a target temperature value.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, the operatingparameter is a measure of the electrical impedance of said energyapplication device, and the first energy coupling condition comprises ameasured electrical impedance magnitude which is substantially similarto a reference waveform of expected electrical impedance of the energyapplication device.

In another variation of the apparatus, the energy application device isadapted to receive power via an electric current, the operatingparameter is a measure of the electrical impedance of said energyapplication device, and the first energy coupling condition comprises ameasured rate of change of the magnitude of the electrical impedance ofthe energy application device which is substantially similar to areference waveform of expected electrical impedance of the energyapplication device.

In another variation of the apparatus, the module is further configuredto terminate or reduce power delivery to the energy application deviceif the operating parameter does not satisfy the first energy couplingcondition within the first time interval.

In another variation of the apparatus, the module is further configuredto cause the warning device to provide a message to a user of theapparatus to adjust the environment of the hollow anatomical structuretreatment device within a patient. In such a variation, the message canoptionally instruct a user to adjust or improve compression of theportion of the hollow anatomical structure containing the treatmentdevice.

In another variation of the apparatus, the module is further configuredto determine whether the operating parameter satisfies a second energycoupling condition within a second time interval following the firsttime interval, and to provide a warning if the operating parameter doesnot satisfy the second energy coupling condition within the second timeinterval. In such a variation, the module can optionally be furtherconfigured to terminate or reduce power delivery to the energyapplication device if the operating parameter does not satisfy thesecond energy coupling condition within the second time interval.

Another embodiment comprises a method of avoiding interference with heattreatment of a hollow anatomical structure within a patient. The methodcomprises initiating power delivery to an energy application device of ahollow anatomical structure treatment device. The energy applicationdevice is disposed within a hollow anatomical structure. The methodfurther comprises measuring an operating parameter of the treatmentdevice. The operating parameter is relevant to energy coupling betweenthe energy application device and its surroundings. The method furthercomprises determining whether the operating parameter satisfies a firstenergy coupling condition within a first time interval following theinitiating. The method further comprises taking corrective measures toimprove the energy coupling between the energy application device andits surroundings, if the operating parameter does not satisfy the firstenergy coupling condition within the first time interval.

In some variations of this method, the operating parameter can be anyone or more of the following: a measure of the temperature of at least aportion of the energy application device; a measure of the powerdelivered to the energy application device; and/or a measure ofelectrical impedance within a current path associated with the deliveryof power to the energy application device.

In some variations of this method, the corrective measures can compriseany one or more of the following: applying compression in the vicinityof the hollow anatomical structure containing the energy applicationdevice; adjusting the location or force of existing compression in thevicinity of the hollow anatomical structure containing the energyapplication device; and/or verifying effective occlusion of flow withinthe hollow anatomical structure in the vicinity of the energyapplication device.

Another embodiment comprises a method. The method comprises sensing atemperature on or near at least a portion of a heat application deviceof a hollow anatomical structure treatment device; determining whetherthe temperature satisfies a required initial temperature condition;receiving a request to initiate power delivery to the heat applicationdevice of the hollow anatomical structure treatment device; andperforming a safety procedure to interrupt a normal power-up process forthe heat application device, if the temperature does not satisfy therequired initial temperature condition.

In one variation of the method, the method further comprises allowing anormal power-up process for the heat application device to proceed ifthe temperature satisfies the required initial temperature condition.

In another variation of the method, determining whether the temperaturesatisfies a required initial temperature condition, comprisesdetermining whether the temperature has satisfied the required initialtemperature condition at any time during a temperature sensing period.In such a variation, the temperature sensing period can optionally beginafter connection of the treatment device to a power source. In such avariation, the temperature sensing period can further optionally endbefore delivery of therapeutic energy from the power source to thetreatment device.

In another variation of the method, the safety procedure comprisespreventing the initiation of power delivery to the heat applicationdevice.

In another variation of the method, the safety procedure comprisesceasing the delivery of power to the heat application device.

In another variation of the method, the required initial temperaturecondition comprises that the temperature meet or exceed a minimumtemperature. In such a variation, the minimum temperature can optionallybe any one or more of the following: significantly above an expectedambient room temperature; substantially at an expected internaltemperature of the hollow anatomical structure to be treated with thetreatment device; and/or 5 to 10 degrees Celsius lower than the normalphysiologic internal temperature of a hollow anatomical structure of thetype normally treated with the treatment device.

In another variation of the method, the required initial temperaturecondition comprises that the temperature fall within an acceptabletemperature range. In such a variation, the acceptable temperature rangecan optionally be any one or more of the following: significantly abovean expected ambient room temperature; bracketing an expected internaltemperature of the hollow anatomical structure to be treated with thetreatment device; and/or bracketing a temperature which is 5 to 10degrees Celsius lower than the normal physiologic internal temperatureof a hollow anatomical structure of the type normally treated with thetreatment device.

Another variation of the method further comprises providing a warning ifthe temperature does not satisfy the required initial temperaturecondition.

Another variation of the method further comprises (a) verifying that theheat application device is properly disposed within a hollow anatomicalstructure of a patient; and (b) manually overriding the safety procedureand initiating a power-up process for the heat application device, ifthe temperature does not satisfy the required initial temperaturecondition.

Another embodiment comprises an apparatus for use in treating a hollowanatomical structure. The apparatus comprises a heat application deviceadapted to receive power from a power source; a user interface adaptedto receive a request from a user to initiate power delivery to the heatapplication device; a temperature measuring device for measuring atemperature within or near the heat application device; and a module incommunication with the temperature measuring device and the userinterface. The module is configured to determine whether a temperaturemeasured by the temperature measuring device satisfies a requiredinitial temperature condition. The module is further configured tofollow a safety procedure to interrupt a normal power-up process for theheat application device if the temperature measured by the temperaturemeasuring device does not satisfy the required initial temperaturecondition.

In one variation of the apparatus, the module is further configured tofollow a normal power-up process for the heat application device if thetemperature measured by the temperature measuring device satisfies therequired initial temperature condition.

In another variation of the apparatus, the module is further configuredto determine whether the temperature has satisfied the required initialtemperature condition at any time during a temperature sensing period.

In another variation of the apparatus, the safety procedure comprisespreventing the initiation of power delivery to the heat applicationdevice.

In another variation of the apparatus, the safety procedure comprisesceasing the delivery of power to the heat application device.

In another variation of the apparatus, the required initial temperaturecondition comprises that the temperature meet or exceed a minimumtemperature.

In another variation of the apparatus, the minimum temperature is abovean expected ambient room temperature

In another variation of the apparatus, the minimum temperature issubstantially at an expected internal temperature of the hollowanatomical structure to be treated with the treatment device.

In another variation of the apparatus, the minimum temperature is 5 to10 degrees Celsius lower than the normal physiologic internaltemperature of a hollow anatomical structure of the type normallytreated with the treatment device.

In another variation of the apparatus, the required initial temperaturecondition comprises that the temperature fall within an acceptabletemperature range. In such a variation, the acceptable temperature rangecan optionally be any one or more of the following: significantly abovean expected ambient room temperature; bracketing an expected internaltemperature of the hollow anatomical structure to be treated with thetreatment device; and/or bracketing a temperature which is 5 to 10degrees Celsius lower than the normal physiologic internal temperatureof a hollow anatomical structure of the type normally treated with thetreatment device.

Another variation of the apparatus further comprises a warning device incommunication with the module, wherein the module is further configuredto cause the warning device to provide a warning if the temperature doesnot satisfy the required initial temperature condition.

In another variation of the apparatus, the user interface is furtheradapted to receive a request from a user to manually override the safetyprocedure; and the module is further configured to initiate a power-upprocess for the heat application device upon receiving a user request tomanually override the safety procedure.

In certain embodiments, a hollow anatomical structure therapy system isdisclosed which comprises: an energy application device suitable forinsertion into a hollow anatomical structure; a power source incommunication with the energy application device, the power sourcecomprising a processor and program instructions executable by theprocessor such that the power source is operable to: (a) deliver powerto the energy application device during a first power delivery phase;(b) measure time elapsing during power delivery; (c) assess performanceof the therapy system during the first power delivery phase; and (d) ifthe performance of the therapy system during the first power deliveryphase is satisfactory, deliver power to the energy application deviceduring a second power delivery phase.

In a further variation, the energy application device is selected fromthe group consisting of an electrically driven heating element, anelectrode, and a laser.

In further variations, the energy application device comprises anelectrically driven heating element with an energy coupling surface, thesurface having a distal-to-proximal length which is at least fifteentimes a width of the heating element.

In further variations, the system further comprises a catheter having ashaft to which the energy application device is coupled.

In other variations, the system further comprises a temperature sensorconfigured to sense at least one of (i) a temperature of at least aportion of the energy application device, and (ii) a temperature oftissue in thermal communication with the energy application device.

In a further variation of the system, the program instructions areexecutable by the processor such that the power source is furtheroperable to: deliver power to the energy application device to reach afirst treatment temperature; and deliver power to the energy applicationdevice to reach a subsequent second treatment temperature which is lowerthan the first treatment temperature.

In a further variation of the system, the program instructions areexecutable by the processor such that the power source is furtheroperable to determine expiration of the first power delivery phase basedon temperature measurement results obtained by the temperature sensor.

In a further variation of the system, the first power delivery phase is10 seconds or less in duration.

In a further variation of the system, satisfactory performance of thetherapy system comprises reaching or exceeding a target temperaturewithin a time limit. In a further variation of the system, the programinstructions are executable by the processor such that the power sourceproceeds to the second power delivery phase only when the temperaturesensor senses the target temperature within the time limit. In a furthervariation of the system, the program instructions are executable by theprocessor such that the power source is further operable to determineexpiration of the first power delivery phase when the temperature sensorsenses a target temperature within a time limit. In a further variationof the system, the time limit is six seconds or less.

In a further variation of the system, the target temperature isapproximately 120 degrees Celsius.

In a further variation of the system, the combined duration of the firstpower delivery phase and the second power delivery phase is 60 secondsor less.

In certain embodiments, a hollow anatomical structure therapy system isdisclosed which comprises: a heat delivery device suitable for insertioninto a hollow anatomical structure; a power source in communication withthe heat delivery device, the power source being programmed to: (a)deliver power to the heat delivery device during a temperature ramp-upphase; (b) measure time elapsing during power delivery; (c) monitoroperation of the heat delivery device; and (d) if the operation of theheat delivery device either during or shortly after the temperatureramp-up phase is acceptable, deliver power to the heat delivery deviceafter the temperature ramp-up phase.

In a further variation of the system, the heat delivery device isselected from the group consisting of an electrically driven heatingelement, an electrode, and a laser. In a further variation of thesystem, the heat delivery device comprises an electrically drivenheating element with an energy coupling surface, the surface having adistal-to-proximal length which is at least fifteen times a width of theheating element.

Another variation of the system further comprises a catheter having ashaft to which the heat delivery device is coupled.

Another variation of the system further comprises a temperature sensorconfigured to sense at least one of (i) a temperature of a portion ofthe heat delivery device, and (ii) a temperature of tissue in thermalcommunication with the heat delivery device.

In a further variation of the system, acceptable operation of the heatdelivery device during or shortly after the temperature ramp-up phasecomprises reaching or exceeding a target temperature within a timelimit. In a further variation of the system, acceptable operation of theheat delivery device during or shortly after the temperature ramp-upphase comprises falling below a target temperature within a time limit.In a further variation of the system, the combined duration of thetemperature ramp-up phase and a subsequent power delivery phase is 60seconds or less.

In a further variation of the system, the power source is furtherprogrammed to: deliver power to the heat delivery device to reach afirst treatment temperature; and deliver power to the heat deliverydevice to reach a subsequent second treatment temperature which is lowerthan the first treatment temperature.

In certain embodiments, a method of treating a hollow anatomicalstructure is disclosed, the method comprising: inserting a heat deliverydevice into a hollow anatomical structure; delivering power to the heatdelivery device during a temperature ramp-up phase; measuring timeelapsing during power delivery; monitoring operation of the heatdelivery device; and if the operation of the heat delivery device duringor shortly after the temperature ramp-up phase is acceptable, deliveringpower to the heat delivery device after the temperature ramp-up phase.

In a further variation, the method additionally comprises: deliveringpower to the heat delivery device to reach a first treatmenttemperature; and delivering power to the heat delivery device to reach asubsequent second treatment temperature which is lower than the firsttreatment temperature.

In a further variation of the method, the heat delivery device isselected from the group consisting of an electrically driven heatingelement, an electrode, and a laser. In a further variation of themethod, the heat delivery device comprises an electrically drivenheating element with an energy coupling surface, the surface having adistal-to-proximal length which is at least fifteen times a width of theheating element.

In a further variation, the method additionally comprises measuring atemperature of at least one of (i) at least a portion of the heatdelivery device, and (ii) a portion of the hollow anatomical structurebeing treated.

In a further variation of the method, monitoring operation of the heatdelivery device comprises determining whether the measured temperaturereaches or exceeds a target temperature within a time limit. In afurther variation of the method, operation of the heat delivery devicecomprises determining whether the measured temperature falls below atarget temperature within a time limit. In a further variation, themethod additionally comprises proceeding to deliver power to the heatdelivery device after the temperature ramp-up phase only when the targettemperature is reached or exceeded within the time limit. In a furthervariation, the method additionally comprises proceeding to deliver powerto the heat delivery device after the temperature ramp-up phase onlywhen the target temperature falls below a target temperature within atime limit.

In a further variation of the method, monitoring operation of the heatdelivery device comprises comparing a measurement of electricalimpedance with a reference waveform.

In a further variation, the method additionally comprises displaying aninstruction to adjust treatment of the hollow anatomical structure ifthe operation of the heat delivery device during the temperature ramp-upphase is not acceptable.

In a further variation of the method, displaying an instruction toadjust treatment of the hollow anatomical structure comprises displayingan instruction to adjust compression of the hollow anatomical structure.

In a further variation of the method, the hollow anatomical structurecomprises a vein.

In certain embodiments, a method is disclosed for treatment of hollowanatomical structures that comprises: inserting an electrically drivenheating element into the hollow anatomical structure, the heatingelement extending distally along a longitudinal axis of the element, theheating element having a length and a width measured orthogonal to thelongitudinal axis, the length being greater than the width; powering theheating element and thereby causing the heating element to reach orexceed a minimal treatment temperature; moving the heating elementwithin the hollow anatomical structure along a lengthwise direction ofthe hollow anatomical structure, and maintaining the heating element ator above the minimal treatment temperature while moving the heatingelement along the lengthwise direction. In a further variation, themovement of the heating element may be initiated after an initial delayafter the minimal treatment temperature is reached.

In further variations of the method, the moving comprises moving theheating element without stopping along a treatment length of the hollowanatomical structure, and the treatment length is greater than theheating element length. In other variations of the method, the movementof the heating element may be temporarily stopped or slowed when thetemperature of the heating element deviates from a target treatmenttemperature by more than 3 degrees Celsius.

In further variations of the method, the minimal treatment temperaturemay be an internal temperature of the heating element, or may be atemperature measured at or adjacent to the heating element. In furthervariations of the method, the minimal treatment temperature issufficient to cause durable reduction of the diameter of the hollowanatomical structure. In further variations of the method, the minimaltreatment temperature is sufficient to cause absence of patency of thehollow anatomical structure. In further variations of the method, theminimal treatment temperature may be within a range of 80-140 degreesCelsius, and may be approximately 120 degrees Celsius or approximately95 degrees Celsius.

In another variation of the method, the heating element is coupled to ashaft of a catheter. In a further variation of the method, heated fluidis delivered from a tip of the catheter while moving the heatingelement. In other variations of the method, the fluid may be passedthrough a lumen of the catheter, heating the fluid with the heatingelement as the fluid passes through the lumen before exiting thecatheter tip.

In a variation of the method, the length of the heating element is atleast equal to fifteen times its width. In a further variation of themethod, the heating element extends to the distal end of the catheter.In a further variation of the method, the heating element may be a coilhaving a variable pitch.

In a further variation of the method, laser light is applied to thehollow anatomical structure with the catheter.

In another embodiment, a method is disclosed for treatment of hollowanatomical structures that comprises: inserting an electrically drivenheating element into the hollow anatomical structure, the heatingelement extending distally along a longitudinal axis of the element, theheating element having a length and a width measured orthogonal to thelongitudinal axis, the length being greater than the width; moving theheating element within the hollow anatomical structure along alengthwise direction of the hollow anatomical structure while applyingelectrical power to the heating element within a treatment power levelrange, and applying power to the heating element within the treatmentpower level range while moving the heating element along the lengthwisedirection.

In a variation of the method, the moving comprises moving the heatingelement without stopping along a treatment length of the hollowanatomical structure, the treatment length being greater than theheating element length.

In a variation of the method, the treatment power level range is 20-40W.

In a variation of the method, the heating element is coupled to a shaftof a catheter.

A variation of the method further comprises delivering heated fluid froma tip of the catheter while moving the heating element. Anothervariation of the method further comprises passing the fluid through alumen of the catheter and heating the fluid with the heating element asthe fluid passes through the lumen before the fluid exits the cathetertip.

In a variation of the method, the length of the heating element is atleast equal to fifteen times the width thereof. In another variation ofthe method, the heating element is a coil having a variable pitch. Inanother variation of the method, the heating element extends to a distalend of the catheter.

A variation of the method further comprises applying laser light to thehollow anatomical structure with the catheter.

In another embodiment, methods are disclosed for treatment of hollowanatomical structures comprising: inserting an electrically drivenheating element into the hollow anatomical structure, the heatingelement extending distally along a longitudinal axis of the element, theheating element having a fixed profile in a plane orthogonal to alongitudinal axis thereof, powering the heating element and therebycausing the heating element to reach or exceed a minimal treatmenttemperature; moving the heating element within the hollow anatomicalstructure along a lengthwise direction of the hollow anatomicalstructure, and maintaining the heating element at or above the minimaltreatment temperature while moving the heating element along thelengthwise direction.

In a variation of the method, the moving comprises moving the heatingelement without stopping along a treatment length of the hollowanatomical structure, the treatment length being greater than a lengthof the heating element.

In a variation of the method, the minimal treatment temperature issufficient to cause durable reduction of the diameter of the hollowanatomical structure. In another variation of the method, the minimaltreatment temperature is sufficient to cause absence of patency of thehollow anatomical structure.

In a variation of the method, the heating element is coupled to a shaftof a catheter.

A variation of the method further comprises delivering heated fluid froma tip of the catheter while moving the heating element. Anothervariation of the method further comprises passing the fluid through alumen of the catheter and heating the fluid with the heating element asthe fluid passes through the lumen before the fluid exits the cathetertip.

A variation of the method further comprises applying laser light to thehollow anatomical structure with the catheter.

In one embodiment, an apparatus for treating a hollow anatomicalstructure is disclosed that comprises: an elongate shaft; a therapeuticenergy application device coupled to the shaft, the energy applicationdevice being sized for insertion into a hollow anatomical structure; andat least one visibility-enhancing element near the energy applicationdevice.

In a variation of the apparatus, the therapeutic energy applicationdevice is coupled to the shaft near a distal end of the shaft.

In another variation of the apparatus, the visibility-enhancing elementis a light emitter. In a further variation, the light emitter is avisible light emitter. In a further variation, the light emitter isconfigured to direct light radially outward, away from a longitudinalaxis of the shaft. In a further variation, a plurality of the lightemitters are spaced radially apart around the longitudinal axis. In afurther variation, the light emitter comprises an optical fiberconnected to a light generator.

In another variation of the apparatus, the visibility-enhancing elementis an ultrasound emitter. In a further variation, thevisibility-enhancing element is a portion of the apparatus that isrelatively highly reflective of ultrasound. In a further variation, thevisibility-enhancing element comprises at least one gas bubble deliveryport. In a further variation, the visibility-enhancing element is aportion of an outer surface of the shaft, which portion is configured totrap one or more gas bubbles.

In another variation of the apparatus, the visibility-enhancing elementis a portion of the apparatus that is relatively highly radiopaque.

In another variation of the apparatus, the energy application device hasa length greater than the width thereof.

In another variation of the apparatus, the energy application device isan electrically driven heater element. In a further variation, theelectrically driven heater element is a closed circuit heating element.

In another variation of the apparatus, the visibility-enhancing elementis configured to facilitate viewing a position of the energy applicationdevice within the hollow anatomical structure.

In another variation of the apparatus, at least one visibility-enhancingelement comprises one visibility-enhancing element next to a proximalend of the energy application device, and another visibility-enhancingelement next to a distal end thereof.

In another variation of the apparatus, the elongate shaft includes aplurality of longitudinally spaced index markings. In a furthervariation, the index markings are spaced apart by approximately a lengthof the energy application device.

In another embodiment, an apparatus for treating a hollow anatomicalstructure is disclosed that comprises: an elongate electrically drivenheater that extends from a distal end thereof to a proximal end thereof;and a visibility-enhancing element adjacent to one of the proximal anddistal ends.

In a variation of the apparatus, the visibility-enhancing element isconfigured to facilitate viewing a position of the electrically drivenheater within the hollow anatomical structure. In a further variation,the visibility-enhancing element is a light emitter.

In another variation of the apparatus, the visibility-enhancing elementis a portion of the apparatus that is relatively highly reflective ofultrasound. In a further variation, the visibility-enhancing elementcomprises a gas bubble delivery port adjacent to one of the proximal anddistal ends.

In another variation of the apparatus, the heater is coupled to anelongate shaft having an outer surface, and the visibility-enhancingelement is a portion of an outer surface of the shaft, which portion isconfigured to trap one or more gas bubbles.

In another variation of the apparatus, the visibility-enhancing elementis a portion of the apparatus that is relatively highly radiopaque.

In another variation of the apparatus, the electrically driven heaterhas a length greater than the width thereof. In a further version, theelectrically driven heater is a closed circuit heater.

In another embodiment, an apparatus for treating a hollow anatomicalstructure is disclosed that comprises: an elongate therapeutic energysource; a first visibility-enhancing element adjacent to a proximal endof the elongate therapeutic energy source; and a secondvisibility-enhancing element adjacent to a distal end of the elongatetherapeutic energy source.

In a variation of the apparatus, the first and secondvisibility-enhancing elements are configured to facilitate viewing aposition of the therapeutic energy source within the hollow anatomicalstructure. In a further variation, the first and secondvisibility-enhancing elements are light emitters. In a furthervariation, the first and second visibility-enhancing elements areultrasound emitters. In a further variation, the first and secondvisibility-enhancing elements are portions of the apparatus that arerelatively highly radiopaque.

In another variation of the apparatus, the therapeutic energy source hasa length greater than the width thereof. In a further variation, thetherapeutic energy source has a fixed profile in a plane orthogonal to alongitudinal axis of the therapeutic energy source.

In certain embodiments, systems and methods are disclosed forendovascular vein treatment using a catheter with an integrated heatingelement.

In one embodiment, a catheter comprises an elongate shaft and aresistive heating element located near the distal end of the elongateshaft. A temperature-sensing element is located in proximity to theresistive heating element and may be centered along the length of theheating element or may be offset from center. The resistive heatingelement may comprise a coil, and the coil may be of a constant pitchwind or of a varying pitch.

In one embodiment, a catheter comprises an elongate shaft and aresistive heating element located near the distal end of the elongateshaft. A sheath is slidably disposed on the shaft. The sheath andcatheter are relatively movable between a first configuration, in whichthe sheath substantially covers the entire resistive heating element,and a second configuration in which the sheath covers less than theentire resistive heating element. The resistive heating element maycomprise a coil, and the coil may be of a constant pitch or of a varyingpitch. In certain embodiments, the sheath may have thermally-conductiveand/or insulative properties in order to maintain a particular heatoutput along the heating element while the length of heat input to theHAS is reduced.

In one embodiment, a catheter system comprises an elongate shaft and anenergy-emission element located near the distal end of the elongateshaft. The energy-emission element optionally includes a plurality ofemission segments, and each of the segments is independently operable toemit energy into the surroundings of the energy-emission element.Optionally, the catheter system further comprises a power sourcedrivingly connected to the emission segments. The power source isoperable pursuant to a multiplexing algorithm to deliver power to, andoperate, the emission segments in a multiplexed fashion. In oneembodiment, the energy-emission element comprises a resistive elementsuch as a resistive coil. In another embodiment, the energy-emissionelement comprises a radio frequency (RF) emitter.

In another embodiment, a catheter system comprises an elongate shaft andan energy-emission element located distal of the elongate shaft. Theenergy-emission element has an effective axial length along which theenergy-emission element emits energy. In certain embodiments, theeffective axial length of the energy-emission element is adjustable.

In another embodiment, a catheter comprises an elongate shaft and anexpandable shaft located on a distal portion of the elongate shaft. Anumber of heater elements are expandable by a balloon. The heaterelements may have a wavy, sinusoidal and/or serpentine configuration.

For purposes of summarizing the invention(s) disclosed herein, certainaspects, advantages and novel features of the invention(s) have beendescribed herein. It is to be understood that not necessarily all suchadvantages may be achieved in accordance with any particular embodimentof the invention(s). Thus, the invention(s) may be embodied or carriedout in a manner that achieves or optimizes one advantage or group ofadvantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an overall view of a resistive element system usableto treat a hollow anatomical structure.

FIG. 2 illustrates one embodiment of a catheter sheath in a partiallyretracted position usable with the resistive element system of FIG. 1.

FIG. 3 illustrates a magnified view of an exemplary embodiment of atherapeutic element of a catheter usable with the resistive elementsystem of FIG. 1.

FIG. 4 illustrates a cross-sectional side view of the therapeuticelement (i.e., working end) of the catheter of FIG. 3.

FIG. 5 illustrates a side view of another embodiment of a working end ofthe catheter of FIG. 3.

FIG. 6 illustrates a side view of yet another embodiment of a workingend of the catheter of FIG. 3.

FIG. 7A illustrates a side view of yet another embodiment of a workingend of the catheter of FIG. 3, wherein the working end comprisesmultiple treatment segments.

FIG. 7B is a table depicting an exemplary treatment cycle usable withmultiplexing the treatment segments of the catheter of FIG. 7A.

FIG. 7C illustrates two views of an embodiment of a catheterincorporating external fluid grooves and an external coil electrode.

FIG. 7D illustrates an embodiment of a resistive element system havingmultiple protruding resistive elements.

FIG. 7E illustrates a side view of a resistive element system includingan expandable balloon and a set of fluid ports.

FIG. 8 illustrates another embodiment of a resistive element devicehaving an expandable electrode.

FIG. 9 illustrates yet another embodiment of a resistive element devicehaving an expandable braid electrode.

FIG. 10A illustrates an embodiment of a working portion of a catheterbody with individually expandable loops usable to treat a hollowanatomical structure.

FIGS. 10B-10D illustrate other embodiments of a working portion of acatheter body usable to treat a hollow anatomical structure.

FIG. 11 illustrates an exemplary embodiment of an expandable set ofspline electrodes capable of conforming and contacting a vein wall.

FIG. 12A illustrates an embodiment of the working portion of a catheterhaving a conformable helical electrode axially coiled on a shaft.

FIG. 12B illustrates the electrode of the device of FIG. 12A beingradially expanded by rotation of a distal catheter portion.

FIG. 12C illustrates the electrode of the device of FIG. 12B expandedand compressed distally to remove inter coil gaps.

FIG. 13A illustrates an exemplary embodiment of a strip electrode coiledsubstantially normal to a catheter shaft axis.

FIG. 13B illustrates an exemplary embodiment of the device of FIG. 13Auncoiled to flatten out the multiple strip electrodes.

FIG. 14 illustrates an exemplary embodiment of an indexing treatmentsystem for hollow anatomical structures.

FIG. 15A illustrates an exemplary embodiment of a catheter havingmarkings usable with an embodiment of an indexing treatment system forhollow anatomical structures.

FIG. 15B illustrates an exemplary embodiment of a catheter havingmarkings and illumination holes usable with an indexing treatment systemfor hollow anatomical structures.

FIGS. 16A-16D illustrate another exemplary embodiment of a catheterusable with an embodiment of an indexing treatment system for hollowanatomical structures.

FIG. 16E illustrates another exemplary embodiment of a catheter usablewith an embodiment of an indexing treatment system for hollow anatomicalstructures.

FIG. 16F illustrates a magnified view of an indexing portion of thecatheter of FIG. 16E.

FIG. 16G illustrates another exemplary embodiment of a catheter usablewith an embodiment of an indexing treatment system for hollow anatomicalstructures.

FIG. 16H illustrates exemplary embodiments of introducers usable withembodiments of an indexing treatment system for hollow anatomicalstructures.

FIGS. 17A and 17B illustrate exemplary embodiments of markings usablefor visual verification of indexing positions of a catheter.

FIGS. 18A and 18B illustrate other exemplary embodiments of markingsusable for visual verification of indexing positions of a catheter.

FIG. 19 illustrates an exemplary embodiment of a movable datum deviceusable with an indexing treatment system.

FIG. 20 illustrates another exemplary embodiment of a movable datumdevice usable with an indexing treatment system.

FIGS. 21A-21D illustrates another exemplary embodiment of an indexingdevice usable for treatment of a hollow anatomical structure.

FIG. 22A illustrates an exemplary embodiment of an indexing systemhaving a sensor configured to detect markings on a catheter shaft.

FIG. 22B illustrates another exemplary embodiment of an indexing systemhaving a sensor configured to detect detents on a catheter shaft.

FIG. 23 illustrates an exemplary embodiment of an indexing system havinga temperature sensor.

FIG. 24 illustrates an exemplary embodiment of an indexing system havingmultiple temperature sensors.

FIGS. 25A and 25B illustrate an exemplary embodiment of an indexingdevice usable for facilitating manual indexed movement of a catheter.

FIGS. 26A and 26B illustrate other exemplary embodiments of indexingdevices usable for facilitating manual indexed movement of a catheter.

FIG. 27 illustrates an exemplary embodiment of an indexing device havinglinkage arms usable for facilitating indexed movement of a catheter.

FIGS. 28A and 28B illustrate other exemplary embodiments of an indexingdevice having linkage arms usable for facilitating indexed movement of acatheter.

FIGS. 29A-29E illustrate a method of using the indexing device of FIG.28A to perform an indexed movement of a catheter during a treatmentprocess.

FIGS. 30A and 30B illustrate exemplary embodiments of automatic indexingsystems including a mechanical indexing handle.

FIGS. 31A-31D illustrate exemplary embodiments of indexing systemshaving controls and/or a remote device to control power applied by atherapeutic element during a treatment process.

FIG. 32 illustrates a screen shot of an exemplary embodiment of acontrol system display usable with an indexing system.

FIG. 33 illustrates an exemplary flowchart of an indexed treatmentprocess.

FIGS. 34A-34C illustrate an exemplary flowchart of an embodiment of amethod of use of a system for treating hollow anatomical structures.

FIG. 35 illustrates an exemplary graph depicting temperature, power andresistance values during a treatment process.

FIG. 36A illustrates another embodiment of an indexing treatment systemfor hollow anatomical structures.

FIG. 36B illustrates another embodiment of an indexing treatment systemfor hollow anatomical structures.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The features of the systems and methods will now be described withreference to the drawings summarized above. The drawings, associateddescriptions, and specific implementation are provided to illustrateembodiments of the invention(s) disclosed herein, and not to limit thescope of the disclosure.

In addition, methods and functions of treatment systems or devicesdescribed herein are not limited to any particular sequence, and theacts or blocks relating thereto can be performed in other sequences thatare appropriate. For example, described acts or blocks may be performedin an order other than that specifically disclosed, or multiple acts orblocks may be combined in a single act or block.

FIG. 1 illustrates an embodiment of a resistive element system 10 forapplying energy to a hollow anatomical structure (HAS) (e.g., the wallof the HAS). For example, a HAS may include, but is not limited to, avein, such as a greater saphenous vein, a short saphenous vein, atributary vein, a perforator vein, a varicose vein, or the like. Asillustrated, the resistive element system 10 comprises a catheter 11.The catheter 11 includes a catheter shaft 13, which may be used tomaneuver a distal portion 14 of the catheter 11 into a desired placementwithin the HAS. In certain embodiments, the catheter shaft 13 comprisesa biocompatible material having a low coefficient of friction. Forexample, the shaft 13 may comprise PEEK, Polyethylene or TEFLON®. Inother embodiments, the shaft 13 may comprise Polyimide, HYTREL®, PEBAX®,nylon or any other such suitable material.

In certain embodiments, the catheter shaft 13 is sized to fit within avascular structure that may be between approximately one millimeter andapproximately twenty-five millimeters in diameter and, preferably,between approximately two millimeters and approximately 18 millimeters.For instance, the catheter shaft 13 may have a maximum outer diameter ofbetween approximately four French and approximately eight French and,more preferably, between approximately six French and approximatelyseven French. In yet other embodiments, other sizes of catheters may beused. In certain embodiments, the distal portion 14 transfers energy(e.g., heat) directly to an inner wall of a HAS. The proximal end of thecatheter has a handle 15. In certain embodiments, the handle 15 mayinclude a connection 16 for interfacing with an energy source 18 and aport for fluid or guidewire passage (e.g., a 0.014″, 0.018″, 0.035″ orpreferably a 0.025″ guidewire).

In certain embodiments, the energy source 18 comprises an alternatingcurrent (AC) source, such as an RF generator. In other embodiments, theenergy source 18 comprises a direct current (DC) power supply, such as,for example, a battery, a capacitor, or other energy source such aswould be used for microwave heating. The energy source 18 may alsoincorporate a controller that, through the use of a processor, appliespower based at least upon readings from a temperature sensor 12 orsensors (e.g., a thermocouple, a thermistor, a resistance temperaturedevice, an optical or infrared sensor, combinations of the same or thelike) located in the working portion (e.g., therapeutic portion) of thecatheter 11. For example, the controller may heat the tissue of a HAS orthe therapeutic region of the catheter to a set temperature. In analternative embodiment, the user selects a constant power output of theenergy source 18. For example, the user may manually adjust the poweroutput relative to the temperature display from the temperature sensor12 in the working portion of the catheter 11.

FIG. 1 thus illustrates one embodiment of a hollow anatomical structuretherapy system. The system comprises an energy application devicesuitable for insertion into a hollow anatomical structure; a powersource in communication with the energy application device, the powersource comprising a processor and program instructions executable by theprocessor such that the power source is operable to: (a) deliver powerto the energy application device during a first power delivery phase;(b) measure time elapsing during power delivery; (c) assess performanceof the therapy system during the first power delivery phase; and (d) ifthe performance of the therapy system during the first power deliveryphase is satisfactory, deliver power to the energy application deviceduring a second power delivery phase.

In variations of this system, the energy application device may be anelectrically driven heating element, an electrode, or a laser. Theelectrically driven heating element may comprise a coil or any otherheating element structure known in the art, and is provided with anenergy coupling surface for applying energy to the hollow anatomicalstructure being treated. In a further variation, the distal-to-proximallength of the heating element along the energy coupling surface is atleast fifteen times the width of the heating element. The electrode maybe any electrode known in the art suitable for applying energy to ahollow anatomical structure. Furthermore, the laser employed may be anylaser known in the art to be suitable for applying energy to a hollowanatomical structure.

In further variations of the system, the energy application device maybe coupled to the shaft of a catheter suitable for insertion into ahollow anatomical structure such as a vein to facilitate the placementof the energy application device within the hollow anatomical structure.Conventional catheters sized to access small vasculature that are knownin the art may be employed for this purpose.

In other variations of the therapy system, the system may also comprisea temperature sensor configured to sense either or both of (i) atemperature of at least a portion of the energy application device, and(ii) a temperature of tissue in thermal communication with said energyapplication device. The temperature sensor may comprise a thermocouple,a thermistor, a resistive temperature device (RTD) or a set of contactsthat measures resistance. FIG. 1 shows an example of this in which thetemperature sensor 12 is placed at the distal portion 14 of the catheter11.

In other variations of the system, the program instructions areexecutable by the processor such that the power source is furtheroperable to: deliver power to the energy application device to reach afirst treatment temperature; and deliver power to the energy applicationdevice to reach a subsequent second treatment temperature which is lowerthan the first treatment temperature. The program instructions may alsobe executable by said processor such that the power source is furtheroperable to determine expiration of the first power delivery phase basedon temperature measurement results obtained by the temperature sensor.In one variation, the first power delivery phase is 10 seconds or lessin duration. In a further variation, the program instructions areexecutable by the processor such that the power source is furtheroperable to determine expiration of the first power delivery phase whenthe temperature sensor senses a target temperature within a time limit.

In further variations of the system, satisfactory performance of thetherapy system comprises reaching or exceeding a target temperaturewithin a time limit. In further variations, the program instructions areexecutable by the processor such that the power source proceeds to thesecond power delivery phase only when the temperature sensor senses thetarget temperature within the time limit. In one variation, the timelimit is six seconds or less. In a further variation, the targettemperature is approximately 120 degrees Celsius.

In other variations, the combined duration of the first power deliveryphase and the second power delivery phase is 60 seconds or less.

In other embodiments, the hollow anatomical structure therapy systemcomprises: a heat delivery device suitable for insertion into a hollowanatomical structure; a power source in communication with said heatdelivery device, the power source being programmed to: (a) deliver powerto the heat delivery device during a temperature ramp-up phase; (b)measure time elapsing during power delivery; (c) monitor operation ofthe heat delivery device; and (d) if the operation of the heat deliverydevice either during or shortly after the temperature ramp-up phase isacceptable, deliver power to the heat delivery device after thetemperature ramp-up phase.

In further variations, the heat delivery device is selected from thegroup consisting of an electrically driven heating element, anelectrode, and a laser. When the heat delivery device comprises anelectrically driven heating element, the heating element may be providedwith an energy coupling surface having a distal-to-proximal length whichis at least fifteen times the width of the heating element.

In further variations, the system is provided with a catheter having ashaft to which the heat delivery device is coupled.

In further variations, the system is provided with a temperature sensorconfigured to sense at least one of (i) the temperature of a portion ofthe heat delivery device, and (ii) the temperature of tissue in thermalcommunication with the heat delivery device.

In further variations of the system, acceptable operation of the heatdelivery device during or shortly after said temperature ramp-up phasecomprises reaching or exceeding a target temperature within a timelimit. In other variations, acceptable operation of said heat deliverydevice during or shortly after the temperature ramp-up phase comprisesfalling below a target temperature within a time limit. In anothervariation, the combined duration of the temperature ramp-up phase and asubsequent power delivery phase is 60 seconds or less.

In another variation, the power source is further programmed to: deliverpower to the heat delivery device to reach a first treatmenttemperature; and deliver power to the heat delivery device to reach asubsequent second treatment temperature which is lower than the firsttreatment temperature.

For example, in certain preferred embodiments, the energy source 18 maycomprise an RFGPlus™ RF generator supplied by VNUS Medical Technologies,Inc. (San Jose, Calif.). In other embodiments, the energy source 18 maycomprise other types of RF or energy-delivering generators usable topower the working portion of the catheter 11. For example, details of RFgenerators that may be used with the embodiments of the cathetersdisclosed herein are further disclosed in the following patents, theentirety of each of which is hereby incorporated herein by reference tobe considered part of this specification: U.S. Pat. No. 6,071,277,issued Jun. 6, 2000; U.S. Pat. No. 6,152,899, issued Nov. 28, 2000; U.S.Pat. No. 6,165,172, issued Dec. 26, 2000; U.S. Pat. No. 6,179,832,issued Jan. 30, 2001; U.S. Pat. No. 6,200,312, issued Mar. 13, 2001;U.S. Pat. No. 6,237,606, issued May 29, 2001; U.S. Pat. No. 6,258,084,issued Jul. 10, 2001; U.S. Pat. No. 6,322,559, issued Nov. 27, 2001;U.S. Pat. No. 6,401,719, issued Jun. 11, 2002; U.S. Pat. No. 6,638,273,issued Oct. 28, 2003; U.S. Pat. No. 6,752,803, issued Jun. 22, 2004; andU.S. Pat. No. 6,769,433, issued Aug. 3, 2004.

FIG. 2 illustrates another embodiment of a resistive element system 20.As shown, a catheter 21 includes an outer retractable sheath 22. Thesheath 22 is advantageously used to protect the device during placement,facilitate introduction of the device, and/or adjust the exposed axiallength of the resistive element 14 (i.e., therapeutic element) for auser-selected and/or variable treatment length. For example, the sheath22 may be used (e.g., pulled back (proximally) or pushed forward(distally)) to adjust the length of the heated region of the resistiveelement 14 that is exposed to a wall of the HAS. In certain embodiments,the sheath may comprise a material or materials that insulates the innerwall of the HAS from receiving thermal energy above a therapeutictemperature and/or that conducts thermal energy away from the resistiveelement to reduce build-up of heat surrounding the portion of theresistive element that is covered by the sheath.

FIG. 2 further shows an optional sensor 23 coupled to the sheath 22 andthe shaft 13. In other embodiments, multiple sensors are placed alongthe axial resistive element length. For example, an energy source mayadvantageously monitor the individual sensors and use data receivedtherefrom for temperature feedback. In another embodiment, a controllermay monitor for high temperature or low temperature signals. Forexample, an algorithmic process may be used to control the currentapplied to the various wire coils, thus maintaining a substantiallyaxially-uniform temperature and/or heat output.

FIG. 3 illustrates a catheter with a cross-section 4-4 of the resistiveelement 14, which is further depicted in FIG. 4. In one embodiment, athermally-conductive tip 30 or extension near the tip is used to extendheating toward the distal tip of the catheter. In certain embodiments,optional features at or near the distal tip and/or the proximal end ofthe heating coil may assist in ultrasound visibility (e.g., a roughsurface such as caused by grit-blasting, or slots, holes or fins). FIG.4 illustrates a detailed cross-sectional portion of the resistiveelement 14 and internal components of the catheter. As will beappreciated, the distance between the illustrated adjacent coils of theresistive element 14 may be of consistent or varied spacing.

The distal section of the catheter in FIG. 4 shows the resistive element14 covered by a sleeve 47. In one embodiment, the sleeve 47 is athin-walled tube from approximately 0.002 inch to approximately 0.010inch thick. In other embodiments, the sleeve 47 may have a wallthickness of less than 0.00025 inch or of more than 0.003 inch. In oneembodiment, the sleeve 47 comprises a non-stick material such as TEFLON®(FEP, PTFE) and/or a non-stick coating such as silicone or a hydrogel.In other embodiments, the sleeve 47 may comprise PET (polyethyleneterephthalate), polyimide or other thin-walled sleeve material thatremains substantially stable and resists damage at temperatures wellabove the desired temperature range. The sleeve material may also bepreferably chosen to provide uniformity of heating along the full lengthof the heating coil, with a defined temperature offset (e.g., apredictable gradient between the heating coil within the sleeve and theouter diameter which is in contact with the HAS). The material selectionprocess of sleeve 47 may be determined by using polymers withnonconductive or electrically insulative properties. In certainembodiments, it may be desirable to maintain a property of the cathetersurface that gives the user tactile feedback of HAS shrinkage aftertreatment (such as, for example, a detectable slight friction).

FIG. 4 also shows an internal lumen 48 of the catheter, whichcommunicates through an open lumen, such as from a distal tip to aproximal handle. In one embodiment, the lumen 48 is used for delivery offluids, such as for example, saline, a venoconstrictor, sclerosant,high-impedance fluid, physiologic tissue adhesive, hydrogel,combinations of the same or the like. In addition, upon completion oftreatment, a sclerosant and/or a hydrogel may be exuded from the distalcatheter end, allowing for substantially complete vessel occlusion. Forexample, the hydrogel may be biocompatible or bioresorbable. In otherembodiments, the hydrogel may be displaced by the constriction of theHAS resulting from the thermal injury response, which results insubstantially complete occlusion. In those sections of the HAS in whichthe fluid material has not completely compressed the HAS wall, the fluidmaterial may be naturally resorbed by the body.

In yet other embodiments, the lumen 48 may also accommodate a guide wirefor catheter placement. In certain embodiments, the lumen 48 mayaccommodate an optical fiber for additional laser energy delivery and/orto provide guiding illumination to indicate the location of the distalend of the catheter as transmitted and visualized through tissue. In yetother embodiments, the lumen 48 may be of the Rapid Exchange variety toallow a guidewire to pass through a distal portion of the cathetershaft.

In certain embodiments, the resistive element 14 of the catheter is madeof resistive wire that generates heat when an energy source (e.g.,energy source 18 of FIG. 1) is connected and applied thereto. As shownin FIG. 4, the resistive element 14 comprises a wire having a roundcross-section, wound on top of an inner shaft layer or layers 46. Inparticular, the resistive element 14 may comprise a round bifilar wirehaving an insulative layer that holds wires together. In certainembodiments, the insulative layer preferably comprises a polyimide orlike material. In certain preferred embodiments, a spacing ofapproximately one-half the wire diameter exists between the insulativelayers of adjacent bifilar wires. As shown in FIG. 4, a temperaturesensor 11, such as a thermocouple, is incorporated into the resistiveelement by being located within a suitable gap between coil windings.

In other embodiments, the cross-section of the resistive element 14 mayalternatively be oval, rectangular, or another geometricalcross-section. Preferably, the relative resistance or impedance of theresistive element 14 is designed to correlate to, or match, the energysource. For example, the resistance of resistive element 14 may bedetermined by a wire gage that relates to the catheter diameter, theenergy required during treatment, and/or the energy sourcespecifications. The resistive element 14 may comprise a wide variety ofconductive materials, such as, for example, nickel chromium (NICHROME®),Alloy 52, copper, stainless steel, titanium, zirconium, NITINOL®,ALUMEL®, KANTHANAL®, CHROMEL®, KOVAR®, combinations or alloys of thesame and the like. The material for the resistive coil or resistiveelement 14 can be chosen to provide Resistance Temperature Detector(RTD) functionality, wherein temperature is indirectly measured as afunction of impedance. Alloy 52 is considered to be one materialsuitable for providing RTD functionality to the resistive element 14.

The resistive element 14 illustrated in FIG. 4 is nearly a close-pitch(or closed-wind) coil (i.e., with very little inter-coil spacing). Inone embodiment, an electrical connection, such as soldering at theproximal end and/or the distal end of the coil, couples the resistiveelement 14 to signal wires 49. As shown in FIG. 4, the signal wires 49are coupled at the distal end of the resistance coil. For example, thesignal wire 49 may connect at the distal end of the resistive element 14and run internally the length of the catheter to a connector cable. Inone embodiment, the signal wires 49 extend from the proximal end of thecoil. In such an embodiment, the signal wire 49 is preferably a largergage copper wire (e.g., 28 to 34 gage) to reduce possible heating withinthe main body of the catheter.

The radially outwardly disposed portions of the resistive element 14function as an energy coupling surface which extends generally along thelength of the resistive element. When the resistive element 14 comprisesa coil, the energy coupling surface typically comprises the (roughly)cylindrical outer surface of the coil, and extends from the proximaledge of the coil to the distal edge thereof. In this example, thecylinder comprises an energy-coupling surface in that substantially theentire cylinder becomes heated and transfers heat to the surroundingportions of the HAS in a typical treatment. Where additional, highlythermally conductive portions are positioned longitudinally adjacent tothe coil, these outer surfaces of these portions can be considered partof the energy coupling surface, if the adjacent portions reach atreatment temperature during normal operation of the coil. Thus, forcoil-type resistive elements, the energy coupling surface extends alongthe entire active portion of the coil, and along any thermally activeportions adjacent to the coil. Where the catheter includes a coating(such as a lubricious coating) over the coil, the outer surface of thecoating can be considered an energy coupling surface, as heat transferto the HAS will take place where portions of the HAS contact (or areotherwise in thermal communication with) the outer surface of thecoating.

When in the form of a resistive heating coil, the resistive element 14generates heat internally, within the winds of the coil, and transfersheat radially outwardly to the HAS from the central longitudinal axis ofthe coil/catheter. The heat is transferred via the energy couplingsurface (whether the outer coil surface itself or a coating forms theenergy coupling surface) to the inner wall of the HAS, either throughdirect contact and conduction, or through intervening media, such asfluids, etc.

In one embodiment, the resistive element 14 comprises a constant,closed-pitch coil. Alternatively, the resistive element 14 may have avarying pitch and/or a varying inter-coil spacing. For example, avarying coil pitch and/or spacing may be advantageously used to vary theheat output over the axial length of the resistive element 14. Anaxially (and/or radially) varying heat output from the resistive element14 may be useful in providing a substantially uniform tissue and/ordevice temperature during treatment.

For example, such a variation in coil pitch may be advantageous insituations involving fluid flow within the HAS. In such embodiments,wherein fluid runs from the direction of the proximal end of thecatheter towards the distal end of the catheter, fluid tends to absorbheat output from the proximal portion of the resistive element 14 to agreater degree than heat output from the distal portion. Such may resultin a reduction of the heat actually applied to the wall of the HASadjacent to the proximal portion of the resistive element 14 relative tothe central and distal sections. As the fluid flows past the proximalsection of the resistive element 14, the fluid itself is heated. Theheated fluid then flows across the middle and distal sections of theresistive element 14, thereby increasing the temperature of treatmentfor these sections. Furthermore, a tighter wind pitch at the ends of theresistance element 14 may balance any edge-effect heating losses thatmay otherwise cause a drop in heat intensity at the ends of theresistance element 14.

Certain embodiments, intended to counteract this uneven heatdistribution, comprise a close-pitch wind of the resistive element 14 inthe proximal portion (providing a higher heat output in the proximalportion), while the middle and distal sections have a comparatively moreopen-pitch wind (i.e., the inter-coil spacing increases in the distaldirection). This configuration advantageously decreases the heat outputalong portions of the coil in order to compensate for the added heatfrom the proximal adjacent sections. That is, the variable coil pitchmay be used to correct for higher temperatures of the middle sections ofthe resistive element 14 in comparison with lower temperatures of theend sections of the resistive element 14. A thermally-insulatingmaterial (such as natural rubber, silicone, or an elastomer) may also beused to shield the internal lumen 48 from heating and/or to selectivelyreduce external heat transfer from the resistive element 14.

In another embodiment, portions of the resistive element 14 having aclose-pitch wind are used to heat larger portions of a HAS (e.g.,portions having a larger diameter) while portions of the resistiveelement 14 having an increased coil spacing are used to heat smallerportions of the HAS (e.g., portions having a smaller diameter).

In other embodiments, the coil wind comprises more than one radiallydisplaced layer. For example, as shown in FIG. 5, a resistive element 50advantageously comprises two layers 54 and 55 of winds that arecounter-wound to overlap. These layers 54 and 55 may also have avariable pitch over the axial length of the catheter shaft. Such aconfiguration may be used to provide a greater heating density and/or toprovide more uniform heating if the coil winds are spaced to increasethe length of the heating segment while using a limited length of coilwire.

In the embodiment shown in FIG. 6, the resistive element comprises abifilar wire coil, which is advantageous in processing since it can bewound as a single filament. A bifilar wire also maintains asubstantially constant distance between the two embedded wires, whichcan help to maintain accurate overall spacing in order to provideuniform heat distribution. In some embodiments, the wind of the bifilarwire coil may comprise a variable pitch, as discussed previously. Incertain embodiments, the bifilar wire coil may also combine wireconnections (i.e., connections between the multiple wires in the wirecoil) at one end of the catheter, such as the proximal end. In certainembodiments, for example, the distal end may also comprise an electricalconnection between the two wire ends in order to create a continuousloop. In alternative embodiments, the bifilar wire may comprise morethan two wires.

FIG. 6 shows a bifilar wire 60 coupled through solder joints 62 tosignal wires 64 and 66. In certain embodiments, the joints 62 are spotwelded or bonded with a conductive epoxy. In addition, the signal wires64 and 66 may extend internally through the catheter shaft to aconnector located at the proximal end (e.g., connector 16 of FIG. 1).FIG. 6 further shows one example of a variable wind configuration, asdiscussed previously.

In other embodiments, energy is applied separately to each wire of thebifilar wire coil. For example, applying energy separately to each wiremay be used to vary and control the power and heat transferred from thedevice to the HAS. In one embodiment, a single coil is used for arelatively smaller HAS, while a plurality of coils are used with arelatively larger HAS.

In another embodiment, as shown in FIG. 7A, a resistive element 70comprises multiple coils or electrodes, which are sequentially placedaxially on the catheter shaft. For example, FIG. 7A illustrates theresistive element 70 including eight such coils, which are identified aselements 71-78. In certain embodiments, each resistive element 71-78 maybe individually temperature controlled and/or may comprise a temperaturesensor. Alternatively, the resistive elements 71-78 may be used in apower control mode that relies on manual energy control.

Alternatively, in embodiments having multiple resistive elements, atemperature sensor is located on the most distal resistive element(e.g., element 71) or other resistive element. For example, the mostdistal resistive element may be used for the initial treatment, and thesuccessive coil electrodes may use the same and/or a predeterminedenergy-time profile.

In certain embodiments, a method of use of the resistive element 70includes multiplexing through each of the resistive elements 71-78 shownin FIG. 7A. The term “multiplex” as used herein is a broad term and isused in its ordinary sense and includes, without limitation, theenergizing or heating of at least one resistive element for a specificdwell time and cascading, or moving, to another resistive element untila final resistive element is reached or until a cycle is completed. Incertain embodiments, the cycle may then be repeated until the completetreatment time is reached.

FIG. 7B depicts a table illustrating the use of the resistive elementconfiguration 70 shown in FIG. 7A. In one embodiment, the resistiveelements 71 through 78 are sequentially energized for a dwell time ofapproximately 0.2 second. In the example shown, three resistive elementsare powered at one time. In particular, the table has shaded blocks oftime that represent the time that energy is delivered to the specifiedresistive elements. Since three resistive elements are powered at onetime, and the dwell time is 0.2 second, each resistive element is on fora total of approximately 0.6 second during one cycle. As illustrated bythe table, for time 0 to time 0.2 second, resistive elements 71, 72 and73 are energized. For time 0.2 second to 0.4 second, resistive elements72, 73 and 74 are energized. This process repeats by stepping throughthe resistive element set. For the eight resistive elements shown, onecomplete cycle takes approximately 1.6 seconds.

In one embodiment, to avoid overcooling a particular resistive element,the cycle time is of a shorter duration and/or the total number ofresistive elements is limited. That is, in certain embodiments, aresistive element may be re-energized before substantial cooling takesplace. In addition, in one embodiment, to increase the treatment zonethe catheter may comprise multiple treatment zones, such as for example,groups of eight resistive elements. Each group of eight resistiveelements may treat the wall of the HAS before energy is applied to thenext group of resistive elements. Alternative modes of multiplexing mayalso be employed. For example, the number of adjacent resistive elementssimultaneously energized may vary. Also, the entire cycle may re-startat the first energized resistive element or the most recent energizedresistive element. Another mode of multiplexing may be accomplishedwhile sensing the tissue impedance. Once a certain impedance level isachieved, the next set of resistive elements is then energized.

Alternatively, at least one of the eight resistive elements 71-78 isenergized to treat the HAS until treatment is complete. Then, the nextresistive element(s) apply heat for a similar treatment time, and so on,moving along the treatment zone. For the eight resistive elements 71-78illustrated in FIG. 7A, the treatment may be for one cycle. For example,resistive element 71 may treat the HAS for approximately 20 seconds.Once resistive element 71 has completed treatment, resistive element 72repeats the treatment for the same treatment time and energy settings.Such a process may continue for resistive elements 73 through 78.

In other embodiments, other treatment cycles may be used. For example,resistive elements 71 and 72 may concurrently treat the HAS forapproximately 20 seconds. Then resistive elements 73 and 74 may apply asimilar treatment, and so forth, through resistive elements 77 and 78 tocomplete the cycle.

FIG. 7C illustrates an embodiment of an electrically resistive heatingelement 80 having an open pitch wind, but omitting the depiction of anouter sleeve. In particular, FIG. 7C shows a coil spacing greatlyexaggerated in order to see details of a catheter tube 82. In oneembodiment, the inter-coil spacing is selected to create a path forfluids. For example, an inner lumen 84 (which is shown as a singlelumen, but may include multiple lumens) of the catheter may deliverfluid to a HAS by pathways 86, which are external surface features andradial holes (intermittently spaced along the grooves) in the tube 82wall. The fluid may be a saline, a venoconstrictor or the like. In onemethod for using the device 80 of FIG. 7C, the device 80 is placed inthe HAS. The HAS is then treated with a venoconstrictor via the catheterlumen 84 and the pathways 86. The HAS is then treated by heating theconstricted wall of the HAS.

FIG. 7D illustrates an embodiment of a resistive heating element 87having separate and distinct protruding resistive elements 88 made ofresistive materials, such as, for example, KANTHANAL®, NICHROME®,CHROMEL®, ALUMEL®, KOVAR®, Alloy 52, titanium, zirconium, combinationsor alloys of the same or the like. In certain embodiments, a series ofresistive elements 88 is spaced axially along a catheter shaft 89,wherein each of the resistive elements 88 comprises adoubly-truncated-spherical body. In one embodiment, each resistiveelement 88 may be further attached to a signal wire by solder, spot weldor other like method. For example, the signal wire may run internal tothe catheter shaft 89 and attach to a cable and/or a connector.

FIG. 7E illustrates another example of a working portion of a catheteraccording to certain embodiments. The device shown has the addition of aballoon 90 expanded by at least one port 91. As shown, the balloon 90 islocated proximate to a resistive element 92. The balloon 90 may be usedin conjunction with the resistive element 92 to occlude or substantiallyocclude a HAS. At least one additional fluid port 93 proximal to theresistive element 92 may also be used for fluid placement within theHAS.

In one embodiment, the catheter is placed in the HAS, and then theballoon 90 is inflated through the at least one port 91. Once theballoon 90 is inflated, the at least one fluid port 93 clears the HAS ofnative fluid, such as blood, distal to the balloon 90 by injecting adisplacing fluid, such as, for example, saline. In one embodiment, thedisplacing fluid is followed by another injection of a venoconstrictor,which reduces the lumen size of the HAS prior to treatment. By atemporary reduction of the size of the HAS, the treatment time used forthe resistive element 92 is advantageously reduced, thereby resulting ina more effective and safe treatment.

Expandable Resistive Element Devices

Serpentine

Another embodiment of a resistive element device 96 is shown in FIG. 8,which incorporates an expandable resistive element 98 on a balloon 100.In one embodiment, the balloon 100 is made of a biocompatible materialsuch as, but not limited to, silicone, PET, urethane, latex, C-FLEX®,combinations of the same or the like. The balloon 100 is attached at oneend to a catheter shaft 101 at the working end of the catheter. Incertain embodiments, both ends of the balloon 100 are sealed on theshaft 101 and are substantially fluid tight. The catheter shaft sectionwithin the balloon 100 may also contain fluid ports (not shown). Theports may be connected to lumen(s) which run internally to the shaft 101to the proximal end. The lumen(s) at the proximal end (e.g., at ahandle) may be further connected to luer components for external fluidconnections. These components may be used to expand and collapse theballoon 100.

The illustrated resistive element 102 is advantageously a serpentinecomponent, which is placed circumferentially around the exterior of theballoon 100 and catheter shaft 101. In one embodiment, the resistiveelement 102 expands circumferentially as the balloon 100 expands. Incertain embodiments, the resistive element 102 is made of NITINOL®. Forexample, the shape memory aspect of NITINOL® may be advantageouslyutilized to help the resistive element 102 remember its expanded orcollapsed position. In other embodiments, other nickel-based springalloys, other spring alloys, 17-7 stainless steel, Carpenter 455 typestainless steel, beryllium copper, or other similar materials may beused.

In an alternative embodiment, the resistive element 102 is locatedwithin the wall of the balloon material or between two layers of thesilicone balloon material. This embodiment results in the serpentineresistive element 102 being more integral to the catheter device 96.

As shown, a temperature sensor 103 is also advantageously attached tothe resistive element 102 for temperature control during application ofenergy to the HAS. In FIG. 8, the sensor 103 is shown attached near aproximal end of the resistive element 102 but may be attached at anypoint axially. In one embodiment, the attachment of the sensor 103 isaccomplished by soldering, bonding or tying the sensor 103 onto thesection of the resistive element 102. Ends 105 of the resistive element102 are attached to signal wires, which may run through an open lumeninternal to the catheter shaft 101 and may be connected to a connectorcable. These signal wires may be attached by solder (or previouslydiscussed methods) to the resistive element 102.

The embodiment of FIG. 8 shows the resistive element 102 being capableof being placed in apposition to the wall of a HAS prior to treatment byuse of the expanding balloon 100. Thus, one device may be advantageouslyadjusted to fit multiple sizes of hollow anatomical structures. Incertain embodiments, the balloon 100 and resistive element 102 may alsocollapse during the last portion of the treatment or as the treatment iscompleted. One intent of collapsing the device 96 during the lastportion of treatment is to maintain apposition with the walls of the HASwhile allowing the tissue to shrink and/or constrict so as to occlude orsubstantially occlude the structure.

For improved viewing of the balloon 100 during expansion, a contrastmedium may be used for fluoroscopy or for an ultrasonic contrast. Forexample, micro bubbles may be employed as part of the balloon fluid forexpansion. Such a configuration may be applicable to any expandableresistive element using a fluid filled balloon.

In certain embodiments, the balloon 100 is capable of displacing asubstance, such as blood, from a treatment area. In another embodiment,the balloon 100 is further capable of directing heat toward the wall ofa HAS by bringing at least a portion of the resistive element 102 inproximity with, or in contact with, the wall. In yet other embodiments,the balloon 100 is configured to collapse in response to the collapsingor narrowing of the HAS and/or is configured to collapse manually.

In one embodiment, an indicator in the handle of the resistive elementdevice 96 shows the state of inflation of the balloon 100. For example,the indicator may comprise a substance or display that moves axially toshow deflation of the balloon 100. For instance, the indicator may becoupled to the expandable member (e.g., the balloon 100), such thatexpansion of the expandable member causes corresponding changes (e.g.,movement) of the indicator. In other embodiments, the out-flowing salineis employed in a pressure or level-gauge like configuration (e.g., athermometer-like configuration) to indicate the state of inflation ofthe balloon 100.

Expandable Braid

FIG. 9 illustrates another embodiment of an expandable resistive heatingelement device 108. The illustrated heating element device 108 utilizesa metal braid wire 109 as the working resistive element. In certainembodiments, the wire 109 is round and/or made of NITINOL®. However, inother embodiments, the braid wire 109 may be a flat wire and/or compriseanother spring-type or shape memory material as discussed above. Theelastic characteristics of NITINOL®, in certain embodiments, arebeneficial to the method of expanding and collapsing the device 108. Inone embodiment, the braid wire 109 is heat set in the nearly fullyexpanded position. In other embodiments, a balloon 110 is used to expandthe braid wire 109.

In one embodiment, the braid wire 109 is sleeved in polyimide to isolatethe multiple wires from each other where they overlap. In otherembodiments, other materials may be used, such as, for example, TEFLON®,urethane, and the like. In certain embodiments, the braid component 109may be created using standard braiding technology. Alternatively, asingle wire may be woven into the braid component 109. The particulardesign of the braid 109 may be selected for the overall resistance orimpedance of the device 108 in view of the corresponding energy sourcebeing used.

The proximal and distal ends of the braid component 109 are captured ina two-part crimp sleeve, 111 and 112, to anchor the ends to a cathetertube 113 and a catheter tube stylet 114. The braid wire 109 in thisembodiment is expanded by the use of the catheter tube stylet 114, whichruns the internal axial length of the catheter from the distal tip 112to a proximal handle. In certain embodiments, the proximal end of thestylet 114 passes through a Touhy Borst type fitting on the catheterhandle and provides, in turn, a handle for stylet manipulation. In suchan embodiment, pushing the stylet 114 distally collapses the braid wire109 (illustrated in the upper portion of FIG. 9), while pulling thestylet 114 expands the braid wire 109 (illustrated in the lower portionof FIG. 9).

In the embodiment illustrated in FIG. 9, the balloon 110 is placedinternal to the braid wire 109 such that the ends of the balloon 110 aredistal to the crimp section 111 and proximal to the crimp 112. Aspreviously discussed, the balloon 110 may comprise silicone, but theballoon 110 can be of other materials previously identified. The balloon110 then uses an internal lumen and side port (not shown) of thecatheter stylet 114 for inflation and/or deflation.

It should be noted that, in certain embodiments, the silicone balloon110 may expand axially and radially when inflated. This may cause theballoon 110 to become “S” shaped for a set axial length of tubing, thuscausing the braid wire 109 to have non-uniform tissue apposition withthe HAS. In such embodiments, to compensate for this configuration, theballoon 110 may be pre-stretched axially just prior to anchoring on thecatheter tubing to the stylet component 114. The stretched balloon 110may then expand radially with little to no axial expansion, depending onthe amount of pre-stretch performed. The balloon 110 may also be used toocclude the HAS to impair blood flow and to remove blood from the braidportion of the catheter. This creates a static fluid volume andadvantageously provides for a more efficient heat treatment. Also, theballoon 110 may promote braid apposition with the HAS. In otherembodiments, the balloon 110 is at least partially expanded andcontracted through expansion and compression of the ends 111 and 112.

In certain embodiments, a temperature sensor 115 is attached to thebraid wire 109 along its axial length. For example, the sensor 115 maybe used for temperature control during the application of energy.Although the sensor 115 is shown attached near the proximal end of thebraid wire 109, the sensor 115 may be located along other portions ofthe braid wire 109. In other embodiments, more than one sensor 115 maybe used.

In another embodiment, the balloon 110 is separate from the braid device109. For example, the balloon 110 may fit within the lumen of the braiddevice 109, and the tips of both the braid device 109 and the balloon110 may connect and anchor to each other. For example, the anchormechanism may include a set of male and female threads appropriatelysized. Alternatively, the tips may be anchored together by use ofaxially aligned holes in both tips, through which a wire is placed andtied off. Alternatively, the tips may be designed with a spring balldetent to anchor the tips together. Alternatively, magnetic orelectromagnetic materials of opposite polarity may be used to align thetips and hold them together.

Expandable Loop

Another embodiment of a resistive element system 118, which is shown inFIG. 10A, utilizes at least one expandable loop 119 that emanates from aside of the main catheter shaft 120. In particular, one end of the loop119 is anchored to the catheter shaft 120. The other end of the loop 119passes through an opening 122 in a sidewall of the catheter shaft 120and runs through the catheter lumen to a handle at the proximal end ofthe catheter shaft 120. In certain embodiments, this second end of theloop 119 functions as a stylet in order to manipulate the shape and/orsize of the loop 119.

In one embodiment, the loop 119 comprises a wire 123 that coils aroundthe main catheter body 120 with spaced attachment points (such as, forexample, by entering into and exiting from segments of a lumen withinthe main catheter body 120). In such an embodiment, by advancing thewire 123 the coils extend beyond the main catheter body 120 as circularcoils extending substantially perpendicular to the axis of the maincatheter body 120. In certain embodiments, the wire 123 is generallycircular in cross-section. In one embodiment, the loop 119 is pre-shapedin order to extend outward toward and/or to contact the walls of a HAS.Alternatively, the wire 123 that forms the actual exposed loop 119 maybe flat, rectangular, ovular, or have other geometrical cross sections.In one embodiment, rotating a stylet handle end of the loop 119manipulates, or twists, the loop 119 toward or away from the cathetershaft 120.

In certain embodiments, the loop 109 may comprise a resistive elementsimilar to the element 14 of FIG. 1. For example the loop 109 maycomprise a resistive element coil. In addition, each loop 109 may have atemperature sensor on the resistive element for use in temperaturecontrolled energy delivery. In other embodiments, each resistive elementmay be covered with a sleeve. For example, the sleeve material maycomprise PET, TEFLON®, polyimide or other like material.

Wavy Expandable Length

Another embodiment of a resistive element system 126 is shown in FIG.10B and utilizes at least one expandable formed set of bends. A mainspline 127, as shown in more detail in FIG. 10D, forms a backbone andis, in certain embodiments, made of NITINOL®. In other embodiments, thespline 127 is made of other nickel-based spring alloys, 17-7stainless-steel, Carpenter 455 type stainless-steel, or beryllium copperor similar materials. As shown in FIG. 10D, the illustrated spline 127is wound with a resistive wire 130, an example of which is discussed inmore detail with respect to FIG. 4. In certain embodiments, the device126 illustrated in FIG. 10A may also include a temperature sensor.Because the illustrated spline 127 slides into a tube 131, the spline127 may comprise an outer sleeve 132 made of TEFLON®, or other likematerial, for reduced frictional force.

In one embodiment, the spline 127 is straightened by withdrawing itproximally into the tube 131. For example, the tube 131 may comprise aninner liner 134, which extends out of the tube end and is formed into anouter lip 133, which is shown in more detail in FIG. 10C. In addition,FIGS. 10A-10C show the wind of the spline 127 as two-dimensional.However, a skilled artisan will recognize from the disclosure hereinthat the spline 127 may also comprise various three-dimensional shapes,such as for example, a helical wind. The particular shape may be used toimprove contact of the heating element to the wall of a HAS duringtreatment.

Expandable Floating Ribbon

FIG. 11 illustrates another embodiment of a resistive element device 135using at least one expandable resistive element. In the illustratedembodiment, pre-shaped splines 136 act as individual resistive heatingelements. The set of splines 136 is attached radially about a cathetershaft 137. In certain embodiments, the spline set 136 has at least oneexpandable resistive element section. In FIG. 11, the illustrated device135 has two expandable sections. As shown, the spline set 136 isanchored at a midpoint 138, which preferably does not substantiallyexpand. A tip 139 and proximal end attached to the shaft 137 alsopreferably do not substantially expand.

In certain embodiments, the device 135 is designed to collapse by use ofan outer sheath (not shown), which in FIG. 11 would be in a retractedposition. For example, the sheath may be used to help place the device135 in the HAS and to help remove the device 135 after treatment. Oneintent of the self-adjusting splines 136 is to allow for expansion suchthat the splines 136 are in apposition to tissue and adjust to any axialbends or curves in the subject HAS. As the HAS is heated duringtreatment, the lumen of the structure constricts and/or shrinks, and thespline set 136 adjusts and collapses concurrently with the lumen. Thissame characteristic also gives the device 135 of FIG. 11 versatility, asit is able to accommodate varying sizes of hollow anatomical structures.

Alternatively, the device 135 comprises a stylet wire similar to thebraid device of FIG. 9 in order to collapse and expand the pre-shapedsplines. In such an embodiment, the splines may be manually collapsedduring treatment in order to follow the occlusion of the HAS.

In certain embodiments, each spline 136 is made of a resistive materialas previously discussed. Alternately, at least one spline 136 may have aresistive coil wire wrapped around it, as is previously described. Incertain embodiments, a temperature sensor may also be attached to atleast one spline 136 for temperature controlled energy delivery.

In certain embodiments, one long expandable section makes up the splineset 136. To support the length during treatment, a balloon may be placedinside the spline set 136. For example, this balloon may use an internallumen of the catheter (not shown) for inflation and deflation.Alternatively, as described for the braid device, the balloon may be aseparate device inserted into the long expandable spline set 136.

As discussed previously with respect to the fixed diameter resistiveelement, the spline resistive elements 136, when individually wired forpower, may also be used advantageously in conjunction with amultiplexing process. Such an embodiment allows for the sequential or“cascading” heating of specific resistive element subsets of the splineset 136. Such multiplexing may involve energizing at least one spline136 for a specific dwell time and then cascading or moving to the nextadjacent spline(s) 136 until the end spline is reached. The cycle isthen repeated until the complete treatment time is reached.

Super Elastic Expanding Ribbon

FIGS. 12A-12C illustrate an embodiment of a treatment catheter with ahelical coil resistive element 140. For example, the coil resistiveelement 140 may be manipulated from a collapsed or small-diameter coiltightly wrapped around the circumference of a catheter shaft (see FIG.12A) into an expanded, large diameter coil (see FIG. 12C). In oneembodiment, the coil 140 comprises a resistive material as discussedearlier. The expanded coil 140 may also be in apposition with the wallof a HAS. In one embodiment, the catheter shaft is made of twoconcentric tubes or shafts, 142 and 143. In such embodiments, theproximal tube 142 may be slightly larger in diameter to fit over thedistal tube 143. The distal tube 143 is capable of rotating about thecatheter tube axis relative to the proximal tube 142. In the illustratedembodiment, clockwise rotation of the distal tube 143 expands theresistive element coil 140 (as shown in FIG. 12C), and counter-clockwiserotation of the distal tube 143 collapses the resistive element coil 140(as shown in FIG. 12A).

FIG. 12A shows the initial collapsed position of the device when, forexample, the catheter is initially placed in the HAS. FIG. 12B shows amid-range of the radial expanding resistive element coil 140, and FIG.12C shows a final state of the device completely expanded. In certainembodiments, the coil 140 is adjusted to eliminate the inter coilspacing by being pushed distally. The steps described may also bereversed to collapse the device for new placement or for removal.

In one embodiment, for the distal tube 143 to rotate and move axially,the distal tube 143 is connected to a torquable stylet wire (not shown).This stylet may run internal to the proximal tube 142 and/or the distaltube 143 and may be accessible at a catheter handle. In one embodiment,the handle also locks the stylet in position in order to maintain theresistive element in a collapsed and/or expanded state.

In certain embodiments, the resistive element 140 is made of NITINOL®having a shape memory property that returns the resistive element 140 toits pre-shaped expanded coil form upon heating. In such an embodiment,one end of the coil 140 may be tethered to the catheter, such as forexample, the proximal end. The expanded coil 140 may also “autocollapse” as the HAS shrinks and/or constricts during the treatment. Inanother embodiment, a sheath is used to retrieve the coil 140 aftertreatment.

FIGS. 13A and 13B show an embodiment of an expandable flat stripresistive element device 145 that includes radially expanding coiledstrips 146. As shown, the device 145 has at least one strip resistiveelement 146. FIG. 13A shows the resistive element 146 collapsed (i.e.,coiled tightly). By rotating a first stylet component 147 in a clockwisedirection, the illustrated resistive element 146 winds up into acollapsed coil. Likewise, by rotating the stylet wire 147 in acounter-clockwise direction, the illustrated coil 146 expands andadjusts to be in apposition with a wall of a HAS. A secondary stylet 148is shown as a stationary component (e.g., not rotatable). In otherembodiments, the stylet 148 may also comprise a catheter tubing orcomponent that attaches to the end of the resistive element 146 and/orthat is rotatable.

FIG. 13B is an example of a 4-resistive element strip version of thedevice 145 of FIG. 13A and is illustrated in a flat, expanded position.In such an embodiment, the resistive element strips 146 compriseresistive material as previously discussed. Stylets 147 and 148 connectto the resistive element strips 146, and the strips 146 heat up whenenergized. Alternatively, the strips 146 may have resistive wire wrappedaround them to form coil-type resistive elements.

In certain embodiments, one or more temperature sensors, as previouslydescribed, may also be attached to at least one strip 146 fortemperature-controlled energy delivery. In addition, strip resistiveelements 146 may be used in conjunction with the multiplexing process toheat specific subsets of the group of resistive elements 146.

In an alternative embodiment, a resistive heating device can beconfigured such that the resistive heating element also acts as aresistance temperature device (RTD). Certain metals exhibit predictablyvarying electrical resistance properties at varying temperatures. Ifthis relationship is known for a given resistive heating element, atemperature of the element can be determined by measuring an electricalresistance across it. Such a system may advantageously eliminate theneed for additional thermocouples or other temperature sensing devicesand/or may provide an independent sensing of temperature forhigh-temperature situations.

Indexing

In some embodiments, it is desirable to provide a heating elementconfigured to treat a relatively short lengths of a HAS at successiveintervals. Such an embodiment can be progressively moved through the HASin a series of discrete steps from a first position to a final positionin order to treat a desired length of the HAS. The process of moving aheating element through a HAS in a series of discrete steps duringtreatment is referred to herein as “indexing.”

A general indexing process may proceed by providing an elongate catheterwith a relatively short-length heating element at a distal portionthereof. The heating element and/or catheter may be inserted through anintroducer sheath into a HAS, such as, for example, a vein. The heatingelement is advanced to a distal-most position, and power is then appliedthereto. The temperature of the subject heating element is allowed toramp up or increase to a desired temperature and remains in place for adesired dwell time. Once the desired dwell time is reached (e.g., thetreatment for the section is completed), the heating element can bepowered down, and the element can be indexed proximally to a secondposition, at which point at least one of the ramp up, dwell, power down,and indexing procedures may be repeated.

FIGS. 14 through 30B illustrate embodiments of short-length heatingelements and indexing systems. It should also be noted that the devicesand structures discussed previously herein may also be used in anindexing system. For exemplary purposes, several of the followingembodiments are described with reference to a coil-type resistiveelement.

For example, FIG. 14 illustrates one embodiment of an indexing HAStreatment system 200 comprising an elongate catheter 202 extendingthrough an introducer sheath 204, which includes a hub 206, and aheating element 208 located at the distal end of the catheter shaft 205.

In certain embodiments, the heating element 208 is an electricallyresistive heating element, including but not limited to any of thosedescribed elsewhere herein, such as any of the embodiments of theresistive element 14 described herein. For example, the heating element208 may comprise a single, bifilar or other electrically resistive wire.The heating element 208 can also comprise multiple, separately operableheater sections (as in the resistive element 70), to provide a heatingelement 208 which has an adjustable active length, or an active regionwhich is adjustable in size. FIG. 14 further illustrates an embodimentof the heating element 208 comprising a wire having tightly-wrappedcoils around a hollow, elongate structure. Thus, the embodiment of FIG.14 can include a heating element 208 in the form of a coil similar tothat shown in partial section in FIG. 4 above. In other embodiments, theheating element 208 may comprise a loose, tight, or variable-pitch coilwound around a solid or hollow elongate structure. In other embodiments,the heating element 208 is composed of an electrically-resistive tubethat can reach and maintain high temperatures (e.g., a solid-stateheater).

In certain embodiments, the heating element 208 has a substantiallyshort axial length. For example, in certain embodiments, the heatingelement 208 has a length of between approximately one centimeter andapproximately ten centimeters. Such a length is believed to beparticularly advantageous for embodiments utilizing manual, externalcompression to treat a HAS. In certain preferred embodiments, the lengthof the heating element 208 is between approximately three centimetersand approximately seven centimeters.

In certain embodiments, the heating energy delivered by the heatingelement 208 of the system 200 is less than 100 watts. In a morepreferred embodiment usable in an indexing process, the heating energydelivered by the heating element 208 is between approximately ten wattsand forty watts.

In certain embodiments, in order to accurately index the heating element208, it is desirable to provide a means for repeatedly moving (orfacilitating accurate, repeated repositioning of) the heating element208 proximally within an HAS undergoing treatment by a desired distance.In certain embodiments, this desired distance is less than the overalllength of the heating element 208 so as to effectively re-treat regionsthat may receive less heat energy as a result of an uneven heatingprofile along the axial length of the heating element 208. It may alsobe desirable to treat more than once a portion of an initial and/orfinal treatment region of the HAS in order to arrange for start- andendpoints of the indexing distances to correspond with catheter shaftmarkings or to arrange that, after the full series of indexedtreatments, the final HAS treatment region is in substantial alignmentwith the end of the introducer sheath 204. It may also be desirable totreat more than once a complete treatment region or regions of the HAS(e.g., for the case of saphenous vein ablation, double-treating thesegment nearest the saphenofemoral junction, in the region nearest alarge tributary vessel, or at an aneurismal vein segment). In addition,in certain embodiments, the system 200 includes means for preventing theheating element 208 from being powered up while it is within theintroducer sheath 204.

In certain embodiments, as illustrated for example in FIG. 15A, thecatheter shaft 205 may comprise a plurality of markings 211 along theaxial length thereof in order to assist in visual verification ofindexing positions. Such markings 211 advantageously assist a user inpositioning and indexing the heating element of the catheter 202 duringtreatment. For example, the user may determine from the markings 211 howfar the heating element should be retracted during a treatment interval.

In certain embodiments, the physician uses the markings 211 to manuallyand selectively move the catheter 202 within a HAS of a patient. Forexample, the catheter 202 may have an associated therapeutic or heatingelement at the end thereof that extends approximately seven centimetersin length. In such an embodiment, the markings 211 may be spaced apartat approximately 6.5 centimeter intervals. When treating the patient,the physician may use the markings 211 to manually withdraw along theHAS the catheter 211 at 6.5 centimeter intervals between successivetreatments of the HAS. Such a 6.5 cm movement can be performed byproceeding from a first state in which a first shaft marking 211 isaligned with a fixed reference point (e.g., the proximal edge of theintroducer sheath hub 206 or other datum as discussed in further detailbelow), then moving the catheter shaft 205 proximally (or distally) toreach a second state in which a proximally (or distally) adjacent secondshaft marking 211 is aligned with the fixed reference point. In otherembodiments, and as discussed in more detail below, a device may be usedto automatically withdraw the catheter at the predetermined intervalsindicated by the markings 211.

In certain embodiments, the location of a therapeutic energy applicationdevice, such as a heating element, within the HAS may be indicated by avisibility-enhancing element. The visibility-enhancing elements may belocated at one or both ends of the therapeutic energy applicationdevice, or may be located along some or all of the length of thetherapeutic energy application device.

In some embodiments, the visibility-enhancing element may facilitate theunmediated visualization of the location of the therapeutic energyapplication device using the naked eye, as for example in the case ofthrough-tissue illumination. For example, FIG. 15B illustrates anembodiment of a catheter that may incorporate one or more light emitterssuch as optical fibers such that an illuminating spot appears at one orboth ends of the therapeutic energy application device throughillumination holes 212. Alternatively, the light emitters may beconfigured to direct light radially outward away from the longitudinalaxis of the elongate catheter shaft. In certain embodiments, such lightemitters may be spaced radially apart around the longitudinal axis ofthe elongate catheter shaft. The illumination may be powered by a lightemitting diode (LED) and battery within the handle of the catheter, byan external light source that may be separate or included as part of thepower generator for therapeutic heating, or by any other device known inthe art for generating light, whether electrically, chemically, or byany other known principle.

In some embodiments, the visibility-enhancing element may facilitate thevisualization of the location of the therapeutic energy applicationdevice mediated by a viewing system, as for example in the case of theuse of ultrasound or radiation-based viewing systems.Visibility-enhancing elements for use with an ultrasound viewing systeminclude, for example, a portion of the apparatus that is rendered highlyreflective of ultrasound. This can be accomplished by, for example,applying a surface treatment to a portion of the apparatus, such as ator near the therapeutic energy application device, such that the surfacemore readily traps gas microbubbles, which reflect ultrasound.Alternatively, the portion can be produced using a specialized coating,comprising a smooth biocompatible polymer coating containingeffervescent agents, that has a microbubble-generating effect. Anexample of such a coating is Phyz™ coating. In a further embodiment, oneor more gas bubble delivery ports may be provided at or near thetherapeutic energy application device, to provide greater contrast whenviewing with ultrasound. Alternatively, the visibility-enhancing elementmay comprise one or more ultrasound emitters, which may employ anystructure known in the art. Furthermore, visibility-enhancing elementsfor use with a radiation-based viewing system include, for example,portions of the apparatus that are relatively highly radiopaque. In oneembodiment, for example, a radiopaque element may be applied at or nearthe therapeutic energy application device. The radiopaque element maycomprise a single, elongate element, such as a wire, wrapped around thetherapeutic energy application device substantially continuously alongthe entire length of the therapeutic energy application device.Alternatively, the radiopaque element may comprise a coating, plating orfilm adhered to the coil along its length. The radiopaque materials usedfor this radiopaque element may comprise, for example, platinum, gold,tantalum, or any other radiopaque material known in the art.

Furthermore, in one embodiment, the therapeutic energy applicationdevice has a length greater than the width thereof. In anotherembodiment, the therapeutic energy application device is a closedcircuit therapeutic energy application device. In another embodiment,the therapeutic energy application device has a fixed profile in a planeorthogonal to the longitudinal axis of the therapeutic energyapplication device.

FIGS. 16A-16D depict one embodiment of the HAS treatment system 200 anda method of its use to treat a vein, such as the great saphenous vein(GSV) as depicted, near its junction with the femoral vein (FV), at thesapheno-femoral junction (SFJ). In other embodiments the system 200 canbe used to treat other HASs, such as other veins.

In certain embodiments, and as depicted in FIG. 16A, the introducersheath 204 is first inserted through the patient's skin S andmanipulated until the distal end of the sheath 204 is within the lumenof the GSV, and the hub 206 remains outside the skin surface. Once thesheath 204 is in place, the catheter 202 is passed distally through thelumen of the sheath 204, and into the GSV until the distal tip of theheating element 208 is positioned at or near the SFJ, as shown in FIG.16A. To facilitate insertion of the catheter 202, in certain preferredembodiments, the introducer sheath may have a minimum inner diameter ofapproximately 2.33 millimeters (approximately seven French). Theposition of the heating element 208 can be monitored or confirmed usingappropriate corporeal vision techniques, such as, for example,ultrasonic imaging.

In the embodiment of FIGS. 16A-16D, the catheter shaft 205 is markedwith first, second, third and fourth marking sections 214, 215, 216,217, which are marked on the shaft 205 in any of the arrangements setforth herein (e.g., alternate colored and/or cross-hatched sections, ora series of tick marks spaced apart from each other by the desiredindexing distance, and/or geometrically coded markers of alternating orvarying shape) so as to make the distal and proximal edges of eachsection 214, 215, 216, 217 easily visible by the user. Thus, the usercan observe the marking section(s) to determine the relative position ofthe heating element 208 within a HAS and/or with respect to theintroducer sheath 204. Preferably, the axial length of each section 214,215, 216, 217 is approximately equal to the length of the heatingelement 208, less any intended overlap distance between treatments. Inone preferred embodiment, the heating element 208 is seven centimetersin length and each section 214, 215, 216, 217 is 6.5 cm in length. Theshaft 205 can be varied in length so as to include more or fewersections than the four depicted in FIGS. 16A-16D.

Generally, the heating element 208 (or an energy coupling surfacethereof) can have a suitable axial length and the length of each section214, 215, 216, 217 can be the heating element length (or energy couplingsurface length) less a decrement which can be between 1% and 15% of theheating element length. This decrement corresponds to a treatmentoverlap length as explained above. In some embodiments, the heatingelement 208 can be between 2 and 10 centimeters in length, and thedecrement can be between 0.1 and 1.5 centimeters. In still otherembodiments, the length of each section 214, 215, 216, 217 can beslightly greater than the length of the heating element 208.

In addition, in certain embodiments the length of the heating element208 is greater than the width thereof. (The width of the heating elementis the greatest dimension (e.g. the diameter) of a cross-section of theheating element 208 taken orthogonal to the longitudinal axis.) Thelength of the heating element can be, in various embodiments, at leastten times the width thereof, or at least fifteen times the widththereof.

The sheath 204 depicted in FIGS. 16A-16D includes a longitudinallyadjustable datum device or reference point indicator 218, which can beemployed to provide a fixed reference for the position of the shaft 205and heating element 208 as discussed in further detail below. Preferablyconnected to the proximal end of the hub 206, the reference pointindicator 218 comprises a reference point 218 a which is longitudinallymoveable relative to the hub 206 via an adjustable section 218 b, whichin the depicted embodiment comprises an accordion section.Alternatively, the adjustable section 218 b can comprise a threadedcylinder or other threaded member (not shown) which engages threads onthe hub 206 to facilitate longitudinal movement of the reference point218 a via rotation of the adjustable section 218 b relative to the hub206. However implemented, the adjustable section 218 b is preferablytransparent, or includes a transparent window or an opening to permitthe user to see the portion of the catheter shaft 205 that passesthrough the adjustable section 218 b proximal of the hub 206.

With resumed reference to the method depicted in FIGS. 16A-16D, once thecatheter 202 is in place in the GSV with the heating element 208 nearthe SFJ (FIG. 16A), the user adjusts the reference point indicator 218by aligning the reference point 218 a with the proximal edge of thefirst marking section 214. In FIG. 16B, this is depicted as a proximalmovement of the reference point 218 a relative to the catheter shaft205, accomplished by longitudinally stretching or extending theaccordion section and then fixing the reference point 218 a in thecorrect position by any suitable means. Where the adjustable section 218b comprises a threaded cylinder or the like, the cylinder is rotateduntil the reference point 218 a reaches the correct position, where itis fixed in position. Alternatively, the user may partially withdraw theintroducer sheath 204 proximally from the GSV until the sheath hub 206or reference point indicator 218 is aligned with an indexing marking(e.g. an indexing marking 219 a), shaft tick mark, marking segment, etc.

Preferably, after alignment of the reference point indicator 218 or theproximal end of the sheath 204 with an indexing marking, etc. asdiscussed above, the user secures the sheath 204 with respect to theGSV, so that the sheath end or reference point indicator 218 can serveas a fixed reference point for indexing of the catheter 202. This can beaccomplished by, for example, securing the sheath 204 to the patient,which can comprise suturing or taping the sheath to the skin of thepatient near the insertion site of the sheath.

The system 200 is now ready for use in treating the GSV as follows. FIG.16B shows the heating element 208 in an initial treatment position nearthe SFJ. At this point, the user activates the heating element 208 bycycling through the steps of powering up the heating element 208,dwelling at a power or temperature state (or series of states), and thenpowering down the heating element 208. Having completed the treatmentcycle for an initial, distal (e.g., limb-proximal) section of the GSV,the user may perform a second treatment closest to the SFJ. The userthen moves the catheter shaft 205 and heating element 208 proximally bythe desired indexing distance (e.g., 6.5 cm), by moving the shaftproximally until the proximal edge of the second marking section (e.g.,to the next tick mark) 215 is aligned with the reference point 218 a(FIG. 16C). The user then repeats the treatment cycle with the heatingelement 208. Following the treatment cycle, the user again moves theshaft 205 and heating element 208 proximally by the indexing distance,pulling the shaft proximally until the proximal edge of the thirdmarking section 216 (e.g., to the next tick mark) is aligned with thereference point 218 a.

This sequence of treatment cycle-index-treatment cycle is repeated untilthe desired length of the GSV (or other vein or HAS) has been treated,at which point the catheter 202 and introducer sheath 204 are removedfrom the treatment area.

In certain embodiments, the fourth or distal-most marking section 217indicates a “stop treatment zone” or a “last treatment zone,” which canbe employed to prevent the heating element 208 from being withdrawn toofar (e.g., into the introducer sheath 204). For example, the fourthmarking section 217 may comprise a band of a solid or patterned colorsuch as red, yellow or other color or pattern that contrasts with thebase color or pattern of the catheter shaft 205.

Furthermore, when implemented as a stop-treatment marker, the fourth ordistal-most marking section 217 preferably has a length that issubstantially equal to the length of the introducer sheath 204 (ratherthan having a length equal to the desired indexing distance as discussedabove), which generally includes, but is not limited to, the followinglengths: five, seven and eleven centimeters. In certain embodiments, aplurality of distinct stop-treatment markers may be used on a singleshaft 205, the plurality of stop-treatment markers corresponding to thevarious lengths of introducer sheaths usable with the catheter 202. Whenemployed, the stop-treatment marker is preferably distinct from theindexing markers. For example, the stop-treatment marker can be of atype, shape, length, color, pattern and/or configuration that differsfrom that employed for the indexing markers.

Thus, when used as a stop-treatment marker, if the proximal edge of thefourth or distal-most marking section 217 is pulled out of the proximalend of the introducer sheath 204 (see FIG. 16D), the user will know thatthe heating element 208 is positioned within the introducer sheath 204.The user can then push the catheter 202 distally until thestop-treatment marker is positioned within the hub of the introducersheath 204, thus avoiding damage to the sheath 204 and/or heatingelement 208.

Where the catheter 202 employs a heating element 208 with an adjustableactive length or adjustable active region as discussed above, theheating element can be operated with a shortened or reduced activelength or region to facilitate treating a “partial” length of the HAS,which is shorter than the entire heating element length. This is usefulfor treating a relatively short portion of the HAS at the beginningand/or end of the treatment process.

In certain embodiments, the indexing process described with reference toFIGS. 16A-16D allows a user to treat selected segments of a HAS forsuccessive periods of time. Furthermore, the markings 214-217 and thereference point indicator 218 of the introducer sheath 204advantageously allow the user to determine the relative position of theheating element 208 within the HAS and/or with respect to the introducersheath 204 through a means external to the body of the patient.

Although described with reference to particular embodiments, other typesor forms of markings may be used with embodiments of the HAS indexingsystem described herein. For example, in certain embodiments, it may bedesirable to provide a unique marker to indicate a final, proximal-most,indexed position so that the corresponding heating element remainsspaced from the introducer sheath by a sufficient distance to preventthe sheath from melting.

As mentioned above, the introducer sheath 204 advantageously includes alongitudinally adjustable reference marker 218. The sheath 204 has alumen which extends from the distal tip of the sheath (shown insertedwithin the GSV in FIG. 16A) to the proximal edge of the hub 206. Thesheath lumen extends generally along a luminal axis in adistal-to-proximal direction, and a portion of the catheter shaft 205 isdepicted as passing through the sheath lumen and along the luminal axisin FIGS. 16A-16D. As seen in FIGS. 16A-16B, the position of thereference marker 218 a is longitudinally adjustable relative to thesheath 204 in the distal-to-proximal direction, along the luminal axis.

In one embodiment, the reference marker 218 is removably coupled to theproximal end of the sheath 204, so that it can be easily removed orattached for use as the surgical situation demands. In furtherembodiments, any of the various reference markers 218 described hereincan be connected (either in a removable fashion, or substantiallypermanently such as by integral formation) to the proximal end of any ofthe sheaths 223 a, 223 b, 223 c shown in FIG. 16H, or to the proximalend of any other suitable sheath type. Advantageously, thelongitudinally adjustable nature of the reference marker 218 facilitatesalignment of the reference marker with one of the indexing markings onthe shaft 205 without need for movement of the shaft 205 relative to thesheath (or vice versa).

FIG. 16E illustrates another embodiment of a catheter 202′ usable totreat a HAS, according to certain embodiments. As shown, the catheter202′ includes a set of markings to inform the user when a heatingelement, or other therapeutic element, of the catheter 202′ isapproaching an introducer sheath. In certain embodiments, such markingsadvantageously prevent a user from drawing the heating element into theintroducer sheath, which may cause damage (e.g., melting) to the sheath.

As shown, the catheter 202′ includes indexing markings 219 a usable tosuccessively treat predetermined lengths of a HAS, as is described inmore detail with reference to FIGS. 16A-16D. For instance, the indexingmarkings 219 a may correspond to the locations of the edges of thefirst, second, third and fourth marking sections 214, 215, 216, 217 ofthe catheter shaft 205 illustrated in FIGS. 16A-16D. In certainembodiments, the indexing markings 219 a are of a width easily visibleby a user, such as for example, approximately 0.2 centimeters.

In certain embodiments, the distance “a” between each of the indexingmarkings 219 a is approximately 6.5 centimeters. In such embodiments,the length of the therapeutic element may extend further than 6.5centimeters, such as approximately seven centimeters, such that thereexists a slight overlap between successive treatment portions. Incertain embodiments, the catheter 202′ may include approximately sixteenindexing markings 219 a. In yet other embodiments, other numbers of, ordistances between, indexing markings 219 a may be used as appropriate.For instance, a catheter with a shorter therapeutic section may utilizea shorter distance between indexing markings.

Generally, in the catheter 202′ of FIG. 16E the therapeutic element orheating element (or an energy coupling surface thereof) can have asuitable axial length and the distance “a” between each of the indexingmarkings 219 a can be the heating element length (or energy couplingsurface length) less a decrement which can be between 1% and 15% of theheating element length. This decrement corresponds to the desiredtreatment overlap length as explained above. In some embodiments, theheating element can be between 2 and 10 centimeters in length, and thedecrement can be between 0.1 and 1.5 centimeters. In still otherembodiments, the distance “a” between each of the indexing markings 219a can be slightly greater than the length of the therapeutic element.

In addition, in certain embodiments the length of the therapeuticelement or heating element of the catheter 202′ is greater than thewidth thereof. (The width of the heating element is the greatestdimension (e.g. the diameter) of a cross-section of the heating elementtaken orthogonal to the longitudinal axis.) The length of the heatingelement can be, in various embodiments, at least ten times the widththereof, or at least fifteen times the width thereof.

The illustrated catheter 202′ further includes a warning section 220 andat least one warning marking 219 b that inform a user that theassociated therapeutic element is approaching the introducer sheaththrough which the catheter 202′ is inserted. For instance, the warningsection 220 may identify the position of the catheter 202′ relative toan introducer sheath during treatment of a final section of the HAS. Incertain embodiments, this final section is the final full-length section(e.g., seven centimeters) treated with the therapeutic section of thecatheter 202′.

In certain embodiments, the warning section 220 includes a distinctcolor and/or pattern that distinguishes the section 220 from otherportions of the catheter 202′. For instance, the warning section 220 mayinclude a red or yellow color. In certain embodiments, the warningsection 220 may also be substantially the same length as the markingsections identified by the indexing markings 219 a. For instance, adistance “b” may be approximately 6.5 centimeters.

The at least one warning marking 219 b advantageously identifies thefurthest point(s) to which the catheter 202′ may be drawn withoutentering the introducer sheath. In particular, the illustrated catheter202′ includes three warning markings 219 b that correspond to threedifferent sized introducer sheaths (e.g., a seven-centimeter sheath, aneleven-centimeter sheath and a fifteen-centimeter sheath). Thesemultiple markings allow for flexibility and/or adaptability in use ofthe catheter 202′ because the user may appropriately manipulate and usethe catheter 202′ with different-length sheaths.

In use, the warning markings 219 b, in combination with the warningsection 220, inform a user when to stop drawing the catheter 202′through the introducer. For instance, the user may utilize the indexingmarkings 219 a as he/she treats successive portions of a HAS. Duringthis treatment process, the user incrementally draws the catheter 202′out of the associated introducer. When the warning section 220 becomesvisible, such as when the warning section 220 as been fully drawn out ofthe introducer (e.g., such that a distal end of the warning section issubstantially flush with an introducer hub), the user is informed thatthe therapeutic element of the catheter 202′ is near the introducersheath.

Subsequent warning markings 219 b further alert the user as to the finalposition(s) of the catheter 202′ before the therapeutic element entersthe introducer sheath. As shown, each of the warning markings 219 bincludes an associated alphanumeric marking that corresponds to acertain-length introducer sheath. For instance, the three illustratedwarning markings 219 b include the numbers “7,”, “11” and “15,” whichcorrespond to, respectively, warning markings for a seven-centimeterintroducer sheath, an eleven-centimeter introducer sheath and afifteen-centimeter introducer sheath.

For example, as shown, the warning markings 219 b include a firstwarning marking positioned a distance “d” from a distal end of thecatheter 202′ and includes the alphanumeric character “7.” In certainembodiments, the distance “d” is preferably at least as long as the sumof the length of the therapeutic section and the length of theparticular introducer sheath. For example, the catheter 202′ includes atherapeutic element with its proximal end identified by an elementmarker 219 c and having a length “c” of approximately eight centimeters,which may include a one-centimeter terminal portion at the distal end ofthe catheter 202′ that is not used for therapeutic treatment. In such anembodiment, the distance “d” preferably would be at least fifteencentimeters in length. Furthermore, in certain embodiments, the diameterof the therapeutic element may be approximately 2.25 millimeters.

Moreover, the catheter 202′ includes a second warning marking positioneda distance “e” from the end of the catheter 202′ and including analphanumeric character “11.” The catheter 202′ also includes a thirdwarning marking positioned a distance “f” from the end of the catheter202′ including an alphanumeric character “15.” In embodiments whereinthe catheter 202′ includes a therapeutic element with a length ofapproximately seven centimeters, plus a one-centimeter terminal portion,the distance “e” is at least nineteen centimeters, and the distance “f”is at least twenty-three centimeters.

In certain embodiments, the catheter 202′ has an overall insertablelength “g” of approximately 100 centimeters. In yet other, embodiments,the catheter 202′ may be shorter or longer as appropriate. For example,the catheter 202′ may have an overall insertable length of approximately60 centimeters.

In certain embodiments, the catheter 202′ comprises a flexible shaft andan inner lumen extending therethrough. For instance, the lumen may beutilized for flushing the catheter 202′ prior to insertion of thecatheter 202′ into the patient and/or for optional use of a guidewire toaid in navigation of the catheter 202′ through the patient's venousanatomy.

Although FIG. 16E depicts one embodiment of the catheter 202′, otherembodiments may include fewer than or more than three warning markings.For instance, another embodiment of the catheter may include onlywarning markings corresponding to two introducer sheath lengths, suchas, for example, seven centimeters and, preferably, eleven centimeters.

FIG. 16F illustrates a magnified view of a portion of the catheter 202′depicted in FIG. 16E. In particular, FIG. 16F illustrates the portion ofthe catheter 202′ having the element marker 219 c, the three warningmarkers 219 b and a portion of the warning section 220.

FIG. 16G illustrates another embodiment of a catheter 202″ usable totreat a HAS, according to certain embodiments. Similar to the catheter202′ of FIG. 16E, the catheter 202″ includes indexing markings 219 a,the warning section 220, warning markings 219 b and a therapeuticelement 208. For example, in certain embodiments, the therapeuticelement 208 may comprise a heating element, such as a resistive heatingelement.

FIG. 16H illustrates three different-sized introducers that are usablein embodiments for treating a HAS. As shown, a first introducer 223 aincludes an introducer sheath 231 a coupled to a fluid conduit 233 athrough an introducer hub 235 a. In certain embodiments, the introducersheath 231 a is inserted through the patient's skin. A treatmentcatheter is then inserted into the introducer hub 235 a and through theintroducer sheath 231 a into a HAS of the patient, such as a vein. Thefluid conduit 233 a further allows for the insertion and/or removal offluids, through the introducer sheath 231 a, into and/or from the HAS.In certain embodiments, the introducer sheath 231 a has a length ofapproximately fifteen centimeters.

As further illustrated in FIG. 16H, a second introducer 223 b includesan introducer sheath 231 b coupled to a fluid conduit 233 b through anintroducer hub 235 b. In certain embodiments, the introducer sheath 231b has a length of approximately eleven centimeters. A third introducer223 c includes an introducer sheath 231 c coupled to a fluid conduit 233c through an introducer hub 235 c. In certain embodiments, theintroducer sheath 231 c has a length of approximately seven centimeters.

FIGS. 17A and 17B illustrate additional catheter shaft markings usablefor performing an indexed treatment process, such as (but not limitedto) the process depicted in FIGS. 16A-16D. FIG. 17A illustrates acatheter having regularly-spaced, alternating colored and/or alternatinglight/dark lines that correspond to desired indexing locations and/ordistances. Such alternating markers advantageously simplify the indexingprocess by removing any need for counting individual centimeter-spacedmarkers on the shaft. Furthermore, the alternating characteristics(e.g., color, pattern) of the markings helps prevent repeated treatmentof the same area.

As shown, the catheter has a first set of markings 221 that alternateswith a second set of markings 222 along the length of the cathetershaft. As shown in FIG. 17B, the marks may alternate between red andwhite colors. The alternating markings may also include referencesymbols, numbers, letters such as “A” and “B,” as shown in FIG. 17A, orother marks in order to further distinguish any given indexing positionfrom the adjacent indexing position(s).

As discussed above, the markings on the catheter shaft 202 of FIGS.17A-17B may be arranged such that the index distances defined betweenconsecutive index step marks are actually shorter than the length of thecorresponding heating element. Again, this encourages intentionaloverlapping of indexed treatments. For example, for a heating elementlength of approximately seven centimeters, the shaft markers 221, 222(e.g., the distance between consecutive A-A or B-B shaft marks) can bearranged to indicate a 6.5 centimeter index step, which may create asubstantially consistent 0.5 centimeter treatment overlap. Such anembodiment may be particularly advantageous when the heating profile isnot consistent across the heating element (e.g., a lower temperature atthe outside edges of the heating element in comparison to thetemperature of a middle portion of a heating element).

Similar to the embodiments discussed above, the catheters of FIGS.17A-17B are used by being placed within a HAS at a desired position foran initial treatment. When the initial treatment is about to start, thephysician or other user notes which catheter shaft marking (e.g., whichletter or color segment) is adjacent to the proximal edge of the hub ofthe introducer sheath (or aligned with whichever reference point ordatum device is employed). If the initial adjacent/aligned shaft markersegment is of a first type (e.g., the mark 221 having the letter “A”with reference to FIG. 17A) then the start of the index step for thesecond treatment is at the start of the next mark of the same type(e.g., the mark 221 having the letter “A” with reference to FIG. 17A) onthe catheter. This arrangement enables the physician to retract theheating element of the catheter proximally by the desired indexingdistance, by moving the catheter until the opposing type of mark isaligned with the hub edge or reference point. Alternatively, thetreatment process is started with “B” and each successive treatment isindexed to the next “B” marker.

Where the proximal edge of the introducer sheath hub is employed as thereference point for positioning and moving the catheter, and if uponinitial catheter placement in a HAS only a partial length of a segmentmarked on the shaft initially extends proximally out of the hub (similarto the situation in FIG. 16A, but without the reference point indicator218), then the physician can simply perform a partial-length index stepafter the initial treatment. In other words, the physician performs afirst treatment cycle with the heating element and catheter in itsinitial placement in the HAS, and then moves the catheter proximally bya partial index distance, until the proximal edge of the next adjacentmarked shaft segment is aligned with the proximal edge of the introducersheath. The usual treatment then proceeds, with one or more“full-segment” treatments.

Alternatively, to address such a situation, the intervals between thealternating shaft markers (e.g., markers 221 and 222, or the distancebetween consecutive A-B shaft marks) may have a length equal toapproximately half of the desired index length in order to reduce thelength of a double-treated section, thereby expediting the overalltreatment process. With markers so arranged, the first catheter movementstops at the first shaft marker encountered, and subsequent cathetermovements are a full index distance in length proceeding to the nextshaft marker of the same type.

Still another way to address the “partial-segment” issue is the use ofan adjustable datum device, as described in more detail above withrespect to the reference point indicator 218 of FIGS. 16A-16D, and belowwith respect to FIGS. 19 and 20. These devices may be used to designatean initial datum point or reference point such that the second treatmentis a full index distance from the initial treatment (in other words,such that the catheter and heating element move a full index distancebetween the initial treatment and the second treatment). Nonetheless, asmentioned above, a double treatment can be performed at the beginningand/or at the end of the treatment procedure (e.g., during the initialand/or final treatment interval) if it is determined that such adouble-treatment would have a beneficial effect on the overall HAStreatment results.

FIG. 18A illustrates another embodiment of an indexing system includinga catheter 224 with regularly-spaced, numbered marks that, when thecatheter 224 is in use, correspond to indexing locations and/ordistances. The catheter 224 includes a heating element 226 at the distalend of the catheter 224 and a sleeve 229 usable to identify the currentindexing position. The illustrated catheter 224 advantageously includesa shaft marked with numerical values for use during the indexingprocess. For example, the numerical values may correspond to the lengthof the catheter 224 portion extending within the HAS or may correspondto the distance of (the proximal end of) the heating element 226 from(the distal end of) the introducer sheath. In yet other embodiments, thenumerical values may correspond to the total length of the treatedportion of the HAS.

As further illustrated in FIG. 18A, the catheter 224 may comprise major(e.g., five-centimeter-increment) markings 227 and 228 that includenumerical values that increase proximally along the catheter shaft 224.Between these major markings 227 and 228 there are additional shaftmarks that comprise a repeated group of the numbers (e.g., 1, 2, 3 and4), letters (e.g., A, B, C and D) and/or shapes (e.g., triangles,circles, diamonds and squares) to designate lengths in between (orotherwise smaller than the distance between) the major markings 227 and228.

In some embodiments, different combinations or sets of numericalmarkings may be used depending on the particular treatment parameters(e.g., heat, time duration, length of HAS treatment portion, and thelike). In yet other embodiments, the catheter 224 may comprise more thanone movable position-indicating sleeve 229. For example, a firstreference marker may be used to indicate the current position of theheating element 226, and a second reference marker may be used toindicate how far the catheter 224 should be re-inserted during atreatment process.

In certain embodiments, the position-indicating sleeve 229 is movable(e.g., slidable) along the shaft of the catheter 224. For example,during a treatment process, a user may slide the position-indicatingsleeve 229 to the edge of a sheath in order to highlight the desiredcurrent numerical value.

In certain embodiments, the shaft markings of HAS indexing catheters asdescribed herein are spaced at repeated intervals, such as for instanceone centimeter. In such embodiments, the major increments (such as fivecentimeters) can have numbers that increase proximally along the shaft.In use, the initial two treatment locations within the HAS may overlapby as much as nearly the full length of the catheter's heating element.In certain embodiments, the increments marked on the catheter shaft maybe in fractional dimensions. For example, in certain embodiments using aseven centimeter heating element, the increments marked on the cathetershaft may be approximately 6.5 centimeters in length.

As shown in FIG. 18B, the distal-most position-indicating sleeve 229 maybe placed against an introducer sheath hub 225 to highlight the currentshaft marking-number for indexing. In such an embodiment, if thetreatment process is interrupted, the position-indicating sleeve 229records catheter position information such that the physician can resumethe treatment process with the heating element in the correct position.In certain embodiments, the sleeve 229 also is capable of remaining in aselectively-fixed position (e.g., due to a friction fit) even when thecatheter 224 is temporarily removed from the introducer sheath hub 225.In such embodiments, the physician is able to advantageously continue atreatment process when returning or replacing the catheter 224 into theintroducer sheath hub 225. With reference to FIG. 18B, a return of thecatheter 224 having the sleeve 229 highlighting the number “2” indicatesthat the next treatment step is the next identical proximal marker(i.e., the number “2” mark (obscured from view in the figure as it iscovered by the sheath) between major markings 227 and 228).

Each of the embodiments depicted in FIGS. 19 and 20 comprises a movabledatum device or reference point indicator usable for establishing astarting position for a first treatment, or otherwise provide a fixedreference point for tracking the position and movement of the catheterand heating element. FIG. 19 illustrates one embodiment of a datumdevice 230 coupled to an introducer sheath hub 232 that serves as anattachment point to a catheter 234. As shown, the datum device 230includes a sleeve, or body, 236 that includes a slot 238 running in anaxial direction such that the ends of the slot 238 do not extend beyondthe length of the sleeve 236. A pointer 240 is slidably positionedwithin the illustrated slot 238. In certain embodiments, the pointer 240is advantageously mounted within the slot 238 such that there issubstantial resistance to sliding, so that the pointer 240 cansubstantially maintain its position as a reference marker. In certainembodiments, the sleeve or body 238 may comprise a transparent orsemi-transparent material, or may include portions removed therefrom,such that index markings 242 on the catheter 234 can be seen as theyapproach the pointer 240.

In certain embodiments, prior to a first heating treatment, the datumdevice 230 is adjusted to point at the nearest catheter shaft marking242. For example, a physician may slide the pointer 240 until it linesup with a shaft marking 242 visible through the sleeve 238. This givesthe physician a starting or reference point so that a fixed-length ormeasured-length index step can be performed by subsequently aligningother of the catheter markings 242 with the pointer 240. In certainembodiments, such a datum device 230 advantageously facilitates accuratealignment of the catheter 234 nearing fractions of a centimeter.

FIG. 20 illustrates an embodiment of a datum device 250 comprising anaxially adjustable sleeve 252 provided adjacent to the proximal end of acatheter 254. In particular, the adjustable sleeve 252 is mountable toan introducer sheath hub 256. In certain embodiments, the tubular sleeve252 attaches directly to the introducer sheath hub 256 and telescopesaxially along the longitudinal axis of the sheath hub 256. In suchembodiments, the sleeve 252 may preferably attach to the hub 256 using asnap fit, a threaded-fit, or another like interface, such that thesleeve 252 maintains its location relative to the hub 256 during use.

In certain embodiments, a proximal end of the sleeve 252 functions asthe datum pointer. In such embodiments, portions of the sleeve 252 arepreferably transparent or semi-transparent so that catheter markings 260may be observed as they approach, or are substantially covered by, areference marker 258 on the sleeve 252. For example, the referencemarker 258 may comprise a colored line, or other identifying feature,that extends at least partially along or near the proximal edge of thesleeve 252.

In use, the adjustable sleeve 252 advantageously provides an adjustabledatum or starting point from which each successive indexing position canbe measured. For instance, the sleeve 252 may be coupled to theintroducer hub 256 through a flexible (e.g., accordion-like) sectionthat allows for extension/retraction of the sleeve 252 axially along thecatheter 254. In other embodiments, the sleeve 252 may be movable (e.g.,slidable) with respect to the hub 256. In yet other embodiments, otherarrangements may be used as appropriate that allow for relative movementbetween the sleeve 252 and the hub 256 to provide for an adjustablereturn point. Such embodiments provide a user with information relatingto a relative positioning of the catheter 254 and facilitates theprevention of a heating element (e.g., at the end of the catheter 254)from entering the introducer sheath. For example, in certainembodiments, and as illustrated in FIG. 20, the datum device 250 mayfurther include a “stop” mark that indicates to the user to ceaseretracting the catheter into the sheath 256. Alternatively, the user maypartially withdraw a sheath such that a portion of the sheath to be usedas a datum (e.g., the proximal edge of the sheath hub) is aligned with acatheter mark.

FIGS. 21A-21D illustrate an example of another embodiment of a HASindexing treatment device 270. In particular, FIG. 21A illustrates thetreatment device 270 as including a catheter 272 comprising a slidableouter sleeve 277 with hub 274 and as having said outer sleeve 277proximate a therapeutic element 280. For example, the therapeuticelement 280 may comprise a heating element usable in the treatment of aHAS, such as in a method of treatment similar to that described withreference to FIGS. 16A-16D. Thus, in various embodiments, thetherapeutic element 280 can comprise any of the devices disclosed hereinas suitable for use as the heating element 208. The illustrated outersleeve 277 further includes a terminal portion 279. For instance, theterminal portion 279 may comprise a different color and/or pattern thanthe remaining portion(s) of the outer sleeve 277. For example, theterminal portion 279 may be a red or yellow color to visually set apartthe terminal portion 279.

FIG. 21B illustrates an equivalent length of an introducer sheath 282next to the terminal portion 279 or the different color and/or patternsection. As this section emerges from the stationary introducer sheath282, the physician is alerted to the proximity of the therapeuticelement 280 to the tip of the introducer sheath 278, whichadvantageously indicates the end of the indexed set of treatments.

In certain embodiments, the therapeutic element 280 is configured tolimit travel of the outer sleeve 277, such as by having an increaseddiameter and/or by providing a physical stop, such as, for example, aring attached to the proximal end of the therapeutic element 280. Incertain embodiments, the outer sleeve 277 is shorter in length than themain body of the catheter 272 by approximately one index section.

In certain embodiments, during use just prior to the initial treatment,the position of the outer sleeve 277 is adjusted (see FIG. 21C) until achange in the markings on the outer sleeve 277 is visible, as is shownin more detail in FIG. 21D. In such an embodiment, a seal or anchorbetween the outer sleeve 277 and the catheter 272 may be loosened andthen the outer sleeve 277 moved proximally relative to the catheter 272while the main shaft of the catheter 272 with heating element 280remains stationary. Once the introducer sheath 282-outer sleeve 277interface reaches the next index step transition, the seal or anchorbetween the outer sleeve 277 and the catheter 272 may be tightened. Suchpositioning advantageously provides a user with a starting point suchthat subsequent full indexed treatment steps can be more easilyperformed.

FIG. 22A illustrates an embodiment of a portion of an indexing systemconfigured to facilitate the positioning of a heating element duringeach indexing step. In particular, the depicted embodiment providesautomatic verification of a catheter position within a HAS withoutrequiring manual, visual or tactile verification of the catheterposition by the physician. In certain embodiments, a plurality ofmechanically, electrically or magnetically detectable markings may beused to indicate to a physician or to an electronic controller systemthat an indexing position has been reached.

For example, as shown in FIG. 22A, a catheter shaft 290 includes aplurality of markings 292 that are detectable by a sensor 294 todetermine the relative position of the catheter shaft 290. In certainembodiments, the markings 292 comprise printed magnetic ink marks thatare detectable by a magnetic reading sensor. In such embodiments, thesensor 294 may be placed adjacent an introducer sheath hub and/or joinedto a controller configured to produce an audible or visible alert wheneach magnetic marker passes underneath the sensor. This system allowsfor the index distance to be tracked and indicated to the physicianvisually and/or audibly without requiring the physician to observe themarkings 292 on the catheter 290. In certain embodiments, the sensor 294may further include an encoder, or other like circuitry, that monitorsthe relative position of the catheter shaft 290 and/or number of indexsteps performed.

In an alternative embodiment, FIG. 22B shows a system 300 that uses aset of detents 302, or grooves, along a main body shaft of a catheter304. A sensor 306, which is configured to detect the detents 302, isadvantageously proximate the catheter main body shaft 304. For example,in certain embodiments, the sensor 306 may attach to an introducersheath hub in order to hold the sensor 306 substantially stationary withrespect to the hub. As the catheter 304 is moved proximally, a follower308 of the illustrated sensor 306 physically “clicks” into each detent302 that passes by the sensor 306.

In certain embodiments, the follower 308 may advantageously comprise aspring-loaded cam that provides an audible and tactile resistanceindicating proper index placement. In other embodiments, the follower308 may comprise a switch, or other like component, connected to asystem controller. Such a switch may inform the system controller thatthe catheter 304 has been indexed to the next position. The systemcontroller may also alert the physician that the catheter 304 is readyfor treatment through audible and/or visual indicators.

FIG. 23 illustrates an embodiment of a HAS treatment system 310 having atemperature sensor 312 placed on a catheter shaft 314. In certainembodiments, the temperature sensor 312 comprises a thermocouple, athermistor, a resistive temperature device (RTD) or a set of contactsthat measures resistance. In certain embodiments, the temperature sensor312 is positioned on the catheter 314 at a distance from a heatingelement 316 approximately equal to the length of an introducer sheath318. In certain embodiments, a control system 320 may advantageouslycommunicate with the temperature sensor 312 through wired or wirelessmeans.

In certain embodiments, the control system 320 monitors the sensedtemperature of the catheter 314 during treatment. For example, thecontrol system 320 may monitor the sensed temperatures to determine whena treatment process has been completed. For instance, when thetemperature sensor 312 detects a significant decrease in temperaturerelative to the patient's body temperature (such as, for example, adecrease to room temperature caused by the temperature sensor 312leaving the HAS and entering the introducer sheath), the control system320 alerts the physician that the treatment is complete. Such an alertmay be, for example, in the form of a visible light, and audible soundand/or another alert signal.

FIG. 24 illustrates another embodiment of a HAS treatment system 330,which includes a catheter distal section 332 having two temperaturesensors 334 and 336. The first temperature sensor 334 is positioned ator near a distal end 338 (e.g., approximately one centimeter from thedistal end 338) of a heating element 340, and the second temperaturesensor 336 is positioned at or near a proximal end 342 (e.g.,approximately one centimeter from the proximal end 342) of the heatingelement 340. In embodiments in which the heating element 340 comprisesan electrically resistive coil, one or more of the temperature sensors334, 336 may be positioned in the coil winds, such as, for example,approximately one-half to approximately one centimeter from an end ofthe coil. In certain embodiments, the temperature sensors 334, 336preferably communicate with a control system 344 configured to determineand compare the temperatures at each end of the heating element 340.

Comparison of temperatures may be advantageous in detecting heating witha portion of the heating element 340 within a sheath. For instance, forthe same power input along the length of the heating element 340, aheating element portion within the sheath may rise to a highertemperature relative to the heating element portion outside the sheath.Furthermore, three or more temperature sensors may be incorporated atthe catheter distal section. Alternatively, a thermocouple locatedproximal to the heating element may be positioned to indicate a coolerair temperature as the catheter shaft exits the introducer sheath.

In certain embodiments, the catheter 332 of FIG. 24 may be placed in aHAS at a desired initial treatment site, which can be located using anyavailable technique. Energy can then be applied to the HAS in an initialtreatment step. After the initial treatment, the catheter 332 is movedproximally, during which time the control system 344 monitors thetemperatures sensed by the two temperature sensors 334, 336. In such atreatment, the section of the HAS treated in the initial step may be ata higher temperature than the surrounding portions of the HAS. Asignificant drop in the temperature detected by the second sensor 336relative to the temperature detected by the first sensor 334 impliesthat the heating element 340 has been at least partially movedproximally out of the previously-heated region. Similarly, a significantdrop in the temperature (e.g., body temperature) detected by the firsttemperature sensor 334 indicates that the heating element 340 has beenindexed to the next adjacent treatment position. In certain embodiments,a power source may be manually activated or programmed to automaticallyengage power once the heating element 340 reaches its next indexedposition.

In certain embodiments, by placing the temperature sensors 334, 336between the ends 338, 342 of the heating element 340, the indexedtreatments may create an overlap of adjacent treatment sections. Inalternative embodiments, the temperature sensors 334, 336 may bepositioned at or closer to the ends 338, 342 of the heating element 340in order to eliminate or reduce the amount of overlap in adjacentindexing positions.

In other embodiments, rather than stopping the heating element at adiscrete series of treatment positions, as described above, it is alsopossible to power the heating element to a target temperature at orabove a minimal treatment temperature and then move the heating elementalong the complete treatment length of the HAS substantially withoutstopping the movement of the heating element while maintaining thetreatment temperature. In one embodiment, the movement of the heatingelement may begin after an initial delay period that commences when theminimal treatment temperature is reached.

In these embodiments, the therapeutic object is to conduct treatmentsubstantially continuously along the full length along which the HAS isto be treated. Unplanned temporary stoppages of the movement of theheating element, for example as a result of the physician becomingdistracted, the patient's position becoming temporarily unfavorable, orfor any other reason, are contemplated within these continuous treatmentembodiments. In other embodiments, the movement of the heating elementmay be temporarily slowed or stopped when the temperature of the heatingelement deviates by a certain amount from the target temperature. In afurther embodiment, this deviation amount is 10 degrees Celsius or less,and may be approximately 3 degrees Celsius in another embodiment.

In one embodiment, the treatment temperature is an internal temperatureof the heating element, or is a temperature measured at or adjacent tothe heating element. In one embodiment, the minimal treatmenttemperature is the temperature required to cause a durable reduction ofthe diameter of the HAS, or to cause an absence of patency in the HAS.This minimal treatment temperature may be within a range of 80-140degrees Celsius, and may be, for example, approximately 120 degreesCelsius or approximately 95 degrees Celsius. Other minimal treatmenttemperatures are contemplated, and may be appropriately set by one ofskill in the art depending on the conditions of use and the desiredtherapeutic outcome.

In another embodiment, power is applied to the heating element within atreatment power level range while the heating element is moved along thetreatment length of the HAS. In a further embodiment, the treatmentpower level range is 20-40 W.

In one embodiment, the heating element may be elongated along itslongitudinal axis, and the treatment length of the HAS is greater thanthe length of the heating element in the direction of movement. In afurther embodiment, the heating element has a length that is at leastfifteen times its width. In another embodiment, the heating element hasa length that is at least ten times its width. In another embodiment,the heating element has a fixed profile in a plane orthogonal to alongitudinal axis thereof.

In a further embodiment, the treatment method also contemplates passingfluid through a lumen of the catheter to which the heating element iscoupled, thus heating the fluid, which then exits at the catheter tip.The fluid may be saline, a venoconstrictor, sclerosant, high-impedancefluid, physiologic tissue adhesive, hydrogel, combinations of the sameor the like. The heating element may extend to the distal end of thecatheter. Furthermore, in one embodiment, the heating element may be acoil with a varying pitch and/or spacing. The varying pitch or spacingmay be advantageously used to vary the heat output over the axial lengthof the resistive element, for example in order to compensate for thecooling effect of the fluid flow and maintain the treatment temperature,to provide a greater treatment temperature at certain areas of the coilfor therapeutic reasons, or for any other reason known in the art. Inone embodiment, the coil pitch is varied so as to provide a highertemperature at the proximal and distal end of the treatment length ofthe HAS.

In a further embodiment, laser light is applied to the HAS from thecatheter to further reduce the patency of the HAS. In a furtherembodiment, the light is applied from the distal end of the catheter.The laser light may be generated by any means known to those of skill inthe art. For example, a 980 nm diode laser may be employed, althoughgeneration of laser light having other wavelengths, for example, withina range of 700-1100 nanometers, is also contemplated.

FIGS. 25A and 25B illustrate embodiments of an indexing device 350usable with systems configured to facilitate regular indexing movementsof a catheter. For example, certain embodiments of the device 350 mayfacilitate reproducible movement of a catheter from a first position asubsequent indexed position.

As illustrated in FIG. 25A, the indexing device 350 includes a pair ofo-ring type donuts 352 and 354 configured to be movably positionable ona catheter shaft. The donuts 352 and 354 are joined together through aconnector 356, such as a string. In other embodiments, the donuts 352and 354 may be connectable through other flexible and/or collapsibledevices such as, for example, wires, springs, and the like.

As further illustrated in FIG. 25B, in certain embodiments, during usethe first donut 352 is positioned on a catheter 358 proximate anintroducer sheath hub 359. In certain embodiments, the first donut 352is manually held against the introducer sheath hub 359. Alternatively,the first donut 352 may be configured to have an interference fit or amechanical luer lock fit to physically and/or mechanically attach to theintroducer sheath hub 359.

The second donut 354 is preferably permitted to move axially along thelength of the catheter 358. In certain embodiments, the second donut 354is further capable of gripping the catheter 358 to move the catheter 358axially as the second donut 354 is moved toward the first donut 352. Forexample, the second donut 354 may comprise a flexible or semi-flexiblematerial that allows a user to squeeze or apply pressure to the seconddonut 354 to grip the catheter 358 extending therethrough.

In certain embodiments, at least one of the donuts 352, 354 comprises anelastic material. For example, at least one of the donuts 352, 354 maycomprise silicone, KRATON®, urethane, combinations of the same or thelike. Such materials may advantageously allow the donut to be pushedonto the catheter shaft and to have an interference fit in order to helpanchor the donut in place until it is manually moved.

In certain embodiments, the device 350 is used to adjust the position ofthe catheter 358 during the treatment of a section of a HAS. Forexample, once the catheter 358 is placed in its initial position suchthat a corresponding therapeutic element (e.g., heating element) islocated at a desired initial treatment site, both donuts 352, 354 areplaced adjacent (such as by sliding at least one of the donuts 352, 354)the introducer sheath hub 359. At that point, the initial treatmentprocess is performed.

Next, the catheter 358 is repositioned for the second treatment process.In certain embodiments, the second donut 354 is used to grip thecatheter shaft 358 and both are moved in tandem away (proximally) fromthe first donut 352 and introducer sheath hub 359 until the movement ofthe second donut 354 and catheter shaft 358 is arrested, or stopped, bythe connector 356. At this point, a therapeutic element of the catheter358 is preferably in a new adjacent section for the second treatment.

In certain embodiments, the connector 356 is preferably of a length thatcorresponds to the length of the desired indexing step. For example, incertain embodiments, the length of the connector 356 may besubstantially the same as the length of the corresponding therapeuticelement. In yet other embodiments, the length of the connector 356 maybe shorter than the length of the therapeutic element such thatsuccessive indexed treatments have a partial overlap. In yet otherembodiments, the length of the connector 356 may be adjustable tofacilitate use of the device 350 with different catheters havingdifferent sized therapeutic elements or to facilitate the adjusting ofthe length of each treated portion.

FIGS. 26A and 26B illustrate alternative embodiments of indexing devicesusable with systems configured to facilitate regular indexing movementsof a catheter. In particular, FIG. 26A illustrates an indexing device360 having a pair of elongated rings 361 and 362 connected by a rigidsliding rod 363. In the illustrated embodiment, the rod 363 extendsthrough openings 364 and 365 of the rings 361 and 362, respectively, andis preferably configured to limit relative axial movement between thefirst ring 361 and second ring 362 beyond a predefined distance. Asshown, the rod 363 further comprises stops 366 at opposing ends of therod 363 that are configured to limit travel of the first and secondrings 361, 362. In particular, the stops 366 comprise a disk-shaped headand are advantageously of a larger size than the openings 364 and 365such that the openings 364, 365 cannot easily pass over the stops 366.

As shown in FIG. 26A, the rings 361 and 362 further comprise catheteropenings 367 and 368, respectively, that allow for a correspondingcatheter to pass therethrough. Use of the indexing device 360 is similarto the use of the indexing device 350 described with reference to FIGS.25A-25B. That is, the elongated rings 361, 362 are used similarly to thedonuts 352, 354 to move a catheter shaft a predefined distance, whichdistance is determined by the length of the rod 363.

FIG. 26B illustrates an alternative embodiment of an indexing device 370that includes first and second rings 371 and 372 having a wish-bone likeshape. In such an embodiment, the legs of at least one of the rings 371,372 may fit around the surface of a catheter shaft. In certainembodiments, such a configuration advantageously allows a user to moreeasily slide at least one of the rings 371, 372 along the catheter shaftand to remove the device 370 from the catheter shaft.

In certain embodiments, at least one of the rings 371, 372 comprises anelastic material. For example, at least one of the rings 371, 372 maycomprise silicone, KRATON®, urethane, combinations of the same or thelike. Such materials may advantageously allow the ring to be pushed ontothe catheter shaft and to have an interference fit in order to helpanchor the ring in place until it is manually moved. In certainembodiments, the rings 371 and 372 may be connectable by a sliding rod,a string, or other like device as described in more detail above.

FIGS. 27, 28A and 28B further illustrate embodiments of indexing devicesemploying various linkages to index a catheter by a desired amount. FIG.27 illustrates an indexing device 374 comprising a linkage with two arms375 and 376. In certain embodiments, the linkage arms 375, 376 are ofsubstantially equal length and are hingedly joined together at one end.In certain embodiments, the range of movement of the linkage arms 375,376 is from approximately 0 degrees (e.g., the arms 375, 376 extendingin parallel directions) to approximately 180 degrees (e.g., the arms375, 376 fully extended). In certain embodiments, the range of motion ofthe arms 375, 376 may be limited by attached cylindrical ends 377 and378 coming together (e.g., at approximately 0 degrees) and when thelinkage arms 375, 376 are in tandem.

As shown, the first linkage arm 375 is connected to the cylindrical end377, and the second linkage arm 376 is connected to the cylindrical end378. In certain embodiments, the first and second cylindrical ends 377,378 are configured to anchor the indexing device 374 to a cathetershaft. For example, the second cylindrical end 378, which may behingedly attached to the linkage arm 376, may be configured to attach toan introducer sheath hub associated with a catheter.

In certain embodiments, the first cylindrical end 377 comprises a gripstructure 380 that is hingedly attached to the linkage arm 375. Forexample, the grip structure 380 may allow the first cylindrical end 377to selectively maneuver along a catheter. In certain embodiments, thegrip structure 380 is configured to straddle a catheter shaft. As shown,the grip structure 380 may comprise an open section that allowsreception of the catheter therein without the need for threading thecatheter through the center of the grip structure 380. The open sectionadvantageously includes two tab-like extensions that a user may pinch(such as with a thumb and a forefinger) to capture the catheter shaft.In certain embodiments, the inner radial surface of the grip structure380 may comprise, for example, a soft tacky type of silicone or KRATON®.

In certain embodiments, during use, the indexing device 374 is coupledto a catheter shaft such that the catheter shaft extends through boththe ends 377, 378. Prior to an initial treatment, the end 378 is movedalong the catheter shaft and brought proximate an introducer hub, andthe end 377 is moved adjacent the end 378. After treatment of thesection has been completed, the user grips the end 377 and draws out thecatheter until the device 374 is in a fully extended position (e.g., thelegs 375 and 376 are in line). Such a full extension preferablycorresponds to the index treatment length. The user then loosens thegrip of the end 377 on the catheter shaft and moves the end 377proximate the end 378. At this point, a second treatment may beperformed and the process is repeated as appropriate.

In certain embodiments, the indexing device 374 may further comprise aspring or elastic component (not shown) further linking the two linkagearms 375 and 376 to keep the device 374 in a preferred position when notin use. For example, such a preferred position may include the gripstructure 380 being located adjacent to the second cylindrical end 378and a corresponding introducer sheath hub.

FIG. 28A illustrates another embodiment of an indexing device 390similar to the indexing device 374 of FIG. 27. As shown, the indexingdevice 390 comprises two sets of arms. In particular, the indexingdevice 390 comprises a top set of arms 392 and 394 that are hingedlyconnected by a first connector 396. The illustrated indexing device 390further comprises a bottom set of arms 398 and 400 that are hingedlyconnected by a second connector 402.

The indexing device 390 also includes a first anchor 404 that ishingedly connected to the first top arm 392 and the first bottom arm398. Likewise, a second anchor 406 hingedly couples the second top arm394 and the second bottom arm 400. In certain embodiments, the secondanchor 406 comprises a structure similar to the cylindrical end 378 ofFIG. 27 and is configured to attach to, or be included as part of, anintroducer sheath hub.

In certain embodiments, at least one of the sets of linkage arms 392,394 and 398, 400 may also include a spring or elastic component to keepthe indexing device 390 in a preferred, or default, position when not inuse. In certain embodiments, the preferred position may include thefirst and second anchors 404 and 406 substantially adjacent to anintroducer sheath hub.

In certain embodiments, the two linkage arms sets are preferably made oftwo structures of substantially equal length. For example, all fourlinkage arms 392, 394, 398 and 400 may be of a substantially equallength, with each pair being hingedly attached together. In certainembodiments, the range of movement of each hinged pair of arms ispreferably from approximately 0 degrees to approximately 180 degrees. Inother embodiments, the range of movement of the hinged arms of thedevice 390 may be limited to narrower ranges as desired.

In certain embodiments, the first anchor 404, includes a grip structurethat is hingedly attached to arms 392 and 398. FIG. 28B illustratesfurther details of inner components of the first anchor 404. Inparticular, FIG. 28B illustrates a portion of a housing 408 of the firstanchor 404. Within a housing 408 are two rings 410 usable, for example,to grip a catheter shaft 412 extending through the first anchor 404. Incertain embodiments, the two rings 410 may provide an interference fiton the catheter shaft 412. When the first anchor 404, for example, ismoved away from an introducer sheath hub, the rings 410 may be movedtoward a tapered inner surface 414 of the housing 408, which may causethe rings 410 to tighten their fit on the catheter shaft 412. In certainembodiments, the tapered inner surface 414 may be of an angle toaccommodate two rings of different sizes, a single ring, or more thantwo rings, for improved gripping forces on the catheter shaft 412.

In certain embodiments, the first connector 396 and second connector 402advantageously facilitate movement of the indexing device 390. Forexample, a user may press on one or both of the connectors 396, 402 toextend the indexing device 390 such that the angles between the sets ofarms increase. Use of the indexing device 390 may be similar to themethod of use described with reference to the indexing device 374 ofFIG. 27.

FIGS. 29A-29E illustrate one method of use of the indexing device 390.For example, a single indexing step during a treatment process. In FIG.29A, the indexing device 390 is in a default or “zero point” positionand is located on the catheter shaft 412 such that the catheter shaft412 extends though the first and second anchors 404 and 406 of theindexing device 390. The first anchor 404 is located proximate thesecond anchor 406, which is adjacent a hub of an introducer 418. Incertain embodiments, the “zero point” position corresponds to theposition and/or configuration of the indexing device 390 duringtreatment of a patient.

FIG. 29A further illustrates the catheter shaft 412 including severalmarkings, including a first mark 420, a second mark 422 and a third mark424. As shown, the first anchor 404 of the indexing device 390 issubstantially aligned with the third mark 424 on the catheter shaft 412.

FIG. 29B illustrates the position of the indexing device 390 during anindexing step. In particular, FIG. 29B illustrates the indexing device390 being in a partially extended position as a result of pressure beingapplied to one or both of the connectors 396, 402. As the user pressesone or both of the connectors 396, 402, the hinged arms of the indexingdevice 390 begin to extend radially (i.e., the angles between each setof arms increases), and the first anchor 404, which advantageously gripsthe catheter 412, draws the catheter 412 from the introducer 418.

FIG. 29C illustrates the indexing device 390 in a fully extendedposition such that the pairs of legs each have approximately a 180degree angle therebetween. In FIG. 29C, a fourth mark 426 along thecatheter shaft 412 also becomes visible as it is drawn from theintroducer 418.

FIG. 29D illustrates a configuration of the indexing device 390 as itreturns to the “zero point” position. In particular, during this returnstate, the first anchor 404 releases its grip on the catheter 412 andslides toward the second anchor 406. Thus, the catheter 412 remainssubstantially stationary during the indexing device's return to the“zero point” position. In certain embodiments, an elastic or spring-likemechanism causes the indexing device 390 to automatically return to the“zero point” position once pressure is released from one or both of thefirst and second connectors 396 and 402.

FIG. 29E illustrates the final state of a single indexing step during atreatment process. In particular, the indexing device 390 is returned tothe “zero point” position. Furthermore, the first anchor 404 issubstantially aligned with the next catheter mark (i.e., the fourth mark426). At this point, a second indexed treatment may be performed.

FIG. 30A illustrates another embodiment of an indexing system 430 thatcomprises a mechanical indexing handle 432. In certain embodiments, theindexing handle 432 is threaded over a main body of a catheter 434. Incertain preferred embodiments, the indexing handle 432 is removable fromthe catheter 434.

As shown, the illustrated indexing handle 432 further comprises a distalend 436 that may be configured to securely attach to a hub of anintroducer sheath. The indexing handle 432 further includes a trigger438, the activation of which causes a corresponding movement of thecatheter 434 through the indexing handle 432. For example, the indexinghandle 432 may be configured to incrementally move proximally the mainbody of the catheter 434 a set distance relative to the introducersheath hub.

In certain embodiments, a catheter cable 440 extends from the catheter434 and is configured to communicate with a remote generator. Forexample, the generator may provide energy to the catheter 434 toactivate a therapeutic element associated therewith.

In certain embodiments, the indexing handle 432 has a set trigger travelor a set index distance. As the trigger 438 is activated, a grippingmechanism within the indexing handle 432 grasps the catheter 434 andmoves the catheter 434 in a proximal direction relative to the indexinghandle 432, which preferably remains stationary. At the end of theincremental movement of the catheter 434, the inner mechanism of theindexing handle 432 then releases the catheter 434 and returns to aninitial position, such as a “zero point” position, within the indexinghandle 432.

In certain embodiments, the inner gripping mechanism comprises astructure similar to the structures described with reference to FIG.28B. In yet other embodiments, the inner gripping mechanism of theindexing handle 432 comprises a cam-action component that is pushedagainst the main body of the handle 432 as the component starts to pullthe catheter 434 and then is released at the end of the travel or indexdistance. In certain embodiments, motive force for the catheter movementmay be provided by a motor-driven worm gear, a pneumatic piston, orother means.

Another embodiment of an index handle 450 is illustrated in FIG. 30B. Asshown, the index handle 450 comprises a first cable 452 and a secondcable 454. In certain embodiments, the first cable 452 extends to aremote generator capable of supplying energy to the catheter 456. Thesecond cable 454 may extend from the indexing handle 450 to a catheter456.

In certain embodiments, the indexing handle 450 may include one or moreswitches or controls for controlling power supplied by the generator tothe catheter 456. For example, the indexing handle 450 may include anON/OFF button to remotely control the power from the generator duringtreatment. In certain embodiments, the indexing handle 450 may comprisea switch that signals the generator to power up or power down.

FIGS. 31A-31D illustrate several embodiments that include a remoteswitch usable to control the supplying of energy to a catheter. Inparticular, FIG. 31A shows a catheter handle 460 connected through acable 462 to a generator 464. The handle 460 further comprises a set ofbuttons 466 usable to control energy supplied by the generator 464.Although two buttons are shown for exemplary purposes, one or morebuttons may be incorporated on the handle 460.

FIG. 31B illustrates an alternative embodiment wherein a catheter handle470 is coupled through a cable 472 to a remote switch 474 separate fromthe handle 470. In certain embodiments, the cable 472 and a cable 476from the generator couple to the catheter handle 470. The remote switch474 and/or switches on the handle 470, for example, may be used tocontrol the associated generator.

FIG. 31C illustrates yet another embodiment showing a remote switch 480directly coupled through a cable 482 to a power generator 484. Alsoshown is a separate cable 486 coupling the generator 484 to an indexinghandle 488. FIG. 31D illustrates a similar embodiment wherein a remotefoot switch 490 is directly coupled through a cable 492 to a generator494. Also shown in FIG. 31D is a second cable 496 coupling the generator494 to an indexing handle 498.

Although described with reference to particular embodiments, otherconfigurations for indexing systems may be used for a treatment processof a HAS. For example, communication between an indexing device and agenerator may take place through wired or wireless (e.g., radiofrequency) communications. In certain embodiments, communicationsbetween one or more switches and/or controls may take place throughwired or wireless communication channels.

FIG. 32 illustrates an embodiment of screen shot of an interface 500 ofan electronic control system usable with embodiments of indexing systemsdisclosed herein. In certain embodiments, software of the control systemdetermines the length and/or number of index steps performed and/or tobe performed based on the information input by the user. For example,relevant information may include, but is not limited to, the length ofthe inserted portion of the catheter and the overall length of theintroducer sheath from its tip to the back end of the hub. Appropriatesoftware modules may then be used to determine the length of an indexstep so that successive treatments can overlap.

As shown, the illustrated interface 500 includes multiple displaycomponents to provide a user with information concerning a treatmentprocess and input devices for receiving information from a user. Inparticular, the interface 500 includes a total elapsed time display 502that indicates how much time has passed since the beginning of theprocedure. An index elapsed time 504 indicates the amount of time passedfor a particular index treatment.

A temperature display 506 provides the temperature of the currenttreatment, and an index step display 508 and a progress display 509indicate which step is currently being performed with respect to theentire treatment process. In certain embodiments, information for one orboth of the index step display 508 and progress display 509 isdetermined by a controller using physician input relating to the lengthof the catheter portion inserted into the introducer and/or the lengthof the introducer sheath.

Although the interface 500 is depicted with reference to a particularembodiment, various other displays and/or input devices may be used.Furthermore, not all display components depicted in FIG. 32 need be partof the interface 500.

FIG. 33 illustrates a general flowchart of an indexing treatment process600, according to one embodiment. In certain embodiments, the process600 is carried out, at least in part, by one of the indexing systemsdescribed previously herein.

As illustrated, the process 600 begins at Block 602 by powering on anindexing treatment system. At Block 604, a generator of the indexingsystem performs a self-check to determine, among other things, if thegenerator is in proper condition to perform a treatment. At Block 606,the catheter is coupled to the generator and a catheter identificationcheck is performed to associate the proper software to the treatmentcatheter. For example, a physician may visually verify that the correctcatheter has been selected, or such verification may be performedautomatically by a control system, such as by electronically reading atag associated with the catheter.

At Block 608, a physician inputs data into the control system indicatingthat the catheter has been inserted into a HAS of a patient.Alternatively, the catheter and/or software may sense body temperatureas an indication that the device has been inserted into the body. Incertain embodiments, the physician inputs the length of the insertedportion of the catheter. In other embodiments, the physician may input aspecific catheter marking that is initially aligned with a introducersheath associated with the catheter.

At Block 610, the physician inputs into the control system the length ofthe introducer sheath. At Block 612, the treatment process begins. Incertain embodiments, a therapeutic element, such as a heating element,of the catheter is energized through the use of at least one powergenerator. For example, the therapeutic element may treat a section ofthe HAS through heat, RF energy, or the like.

Following Block 612, Blocks 614, 616, 618, and 620 may be performedconcurrently or substantially concurrently. At Block 614, anidentification of the specific segment being treated is displayed to theuser. For example, the control system may correlate a first segment witha number “1” and display this number to the user, such as in a mannerdescribed with reference to the display illustrated in FIG. 32. At Block616, an identification of the number of treated segments is displayed.At Block 618, a temperature of the current treatment is displayed. AtBlock 620, the power being currently used during the treatment isdisplayed.

After the treatment for the specific segment has completed, the process600 proceeds with Block 622. At Block 622, the process 600 causes thegenerator to enter a standby mode such that little or no power isapplied to the therapeutic element of the catheter. The process 600 thendetermines at Block 624 whether there are remaining segments of the HASto be treated. If there are segments that remain to be treated, theprocess 600 proceeds with Block 626, wherein the therapeutic portion ofthe catheter is moved to the next segment and an input signal isprovided to the control system to begin the next indexed treatment. Forexample, in certain embodiments, one of the indexing devices describedpreviously herein is used to adjust the catheter position betweensuccessive indexing treatments. If there are no segments remaining to betreated, the process 600 proceeds with Block 628, wherein the physicianpowers down the generator.

Although the process 600 has been described with reference to particularembodiments, the process 600 may be performed without executing all theblocks illustrated in FIG. 33, or some of the illustrated blocks may bemodified. For example, either or both of Blocks 608 and 610 may beperformed automatically by the control system. For instance, in certainembodiments, the control system may monitor the length of the catheterportion inserted into the HAS.

In addition, the order of the blocks illustrated in FIG. 33 may bemodified in other embodiments. For example, the process 600 may performany combination of Blocks 614, 616, 618 and 620 simultaneously or in anyorder to provide the user with the pertinent information relating to thetreatment process.

Certain methods of using an indexing HAS treatment system will now bedescribed. The methods described herein can employ any suitable devicedescribed above or otherwise known to the skilled artisan. In themethods described below, the direction “distal” or “proximal” willgenerally refer to the catheter orientation, wherein “distal” is towardthe catheter end inserted into the body and “proximal” is toward the endthe user holds during operation.

For example, in certain embodiments, an indexing method may compriseinserting a heating element with a length of about five to about sevencm into a distal-most section of a HAS to be treated. For instance, fora saphenous vein, where the catheter is advanced antegrade from the kneearea to the groin area, the catheter-distal direction is limb-proximal).

The heating element is then aligned with the starting treatment locationwithin the HAS. In certain embodiments, a tumescent solution may beinjected to surround and compress the HAS (assisting in evacuation offluid from within the HAS, providing a thermal heat sink to protectsurrounding tissue, and providing anesthetic to the surrounding tissue).Compression of the HAS, such as through manual compression by thephysician, may also be performed.

Power is then be applied to the heating element for a desired length oftime to treat the segment of the HAS adjacent to the heating element.After a desired dwell time, the power supply to the heating element canbe reduced or shut off. With the power off (or substantially reduced),the heating element may then be indexed proximally (i.e., the heatingelement can be moved proximally until the distal end of the heatingelement is adjacent to the proximal end of the previously-treatedsegment of the HAS).

An example of an index treatment includes treatment at a temperaturebetween approximately 95° C. and approximately 150° C. for a dwell timeof approximately twenty seconds or less. In a more preferred embodiment,the preferred index treatment is performed at approximately 120° C. fora dwell time of approximately twenty seconds. The ramp time totemperature may be approximately ten seconds or less, with a preferredtime of approximately four seconds or less. In certain embodiments, theintent of a short ramp time is to advantageously reach and maintain thetreatment temperature quickly in order to apply heat to the HAS in ahighly-localized manner.

In certain embodiments, the HAS heating is advantageously applied for asufficient time to allow thermal conduction along collagen-dense regions(such as a vein wall) to cause fully-circumferential HAS (e.g., vein)wall shrinkage. In certain embodiments, the heating element may beprovided a constant power input, independent of thermal measurement.

Once a section is treated, the distal therapeutic portion of thecatheter is moved to the adjacent section. In certain embodiments, theindexing of the catheter provides an overlap portion of approximatelyone centimeter or less to substantially reduce or eliminate the numberof under-treated sections or gaps as mentioned earlier. This process isrepeated until the treatment of the HAS is complete. In someembodiments, an automatic mode may provide a signal (visual and/oraudible) to the user to alert them when to move the catheter to the nexttreatment section.

In other embodiments, higher temperatures such as, for example,approximately 200° C. or approximately 500° C., at a shorter dwell timeare also possible depending on circumstances of the treatment. In yetother embodiments, the treatment process may comprise a multi-stepheating process, such as a planned initial temperature overshootfollowed by a lower temperature. For example, the HAS may be treated ata first temperature (e.g., approximately 110° C.) for a first portion ofthe process and a second temperature (e.g., approximately 95° C.) for asecond portion of the process. Alternatively, a succession of heatingand dwell periods may be employed (e.g., ten one-second heating periodsspaced by nine one-second off periods, or five three-second heatingperiods at approximately 140° C. spaced by four one-second off periods)to limit the spread of conductive heating such as in the case where thedwell time may allow thermal relaxation. The total energy input to theHAS, as dependant upon the power level over time, may preferably bewithin the range of 40 to 200 Joules per centimeter and, morepreferably, within the range of 70 to 140 Joules per centimeter.

In certain embodiments of the catheter system, fluid may be injectedthrough a lumen of the catheter to flow through a region heated by theheating element such that the injected fluid becomes heated to atherapeutic temperature (e.g., approximately 80-100° C.) to extend thelength of heating along the HAS. The rate of fluid injection may becontrolled by a fluid drip rate within a drip chamber, by a fluid pumpsuch as a peristaltic pump, by regulated pressure input to the lumenoptionally with a resistive orifice, or by other means.

FIGS. 34A-34C illustrate one embodiment of a method of use of a systemfor treating a HAS. In certain embodiments, the treatment system maycomprise one of the indexing treatment systems disclosed herein, such asany of the catheters 202, 202′, 900, 950. For ease of description, eachof FIGS. 34A-34C illustrates one of three different processes or stagesof the method of use. A skilled artisan will recognize, however, thatany of the described processes/stages may be combined into a singleprocess or stage and/or may be subdivided into additional processes orstages.

In particular, FIG. 34A illustrates a catheter preparation process 700that begins with Block 702, wherein a user turns on a generator. Incertain embodiments, the generator may comprise an RF generator, suchas, for example, the RFGPlus RF generator. Once the generator is turnedon, an interface of the generator, such as a display, may prompt theuser to connect an appropriate treatment device, such as one of thecatheter devices disclosed herein, to the generator.

At Block 704, the user couples the catheter device to the generator. Incertain embodiments, to determine if the catheter is properly coupled tothe generator and/or if the appropriate catheter is being used, thegenerator may sense an identification resistor or other identifyinginformation associated with the catheter. In yet further embodiments,the generator may also determine from the identification informationcertain attributes and/or operational characteristics of the attachedcatheter device. For instance, the generator may determine the length ofthe catheter being used (e.g., 60 or 100 centimeters). The generator mayalso specify a certain logic set (e.g., program, or set of defaultparameters) to associate with the catheter being used.

At Block 706, a temperature flag of the generator is raised until atemperature of the attached catheter is greater than 33° C. Such a flag,in certain embodiments, helps prevent a user from powering-up thetreatment system while the catheter is still positioned outside thepatient's body. For instance, the temperature may be read from one ormore temperatures sensors or like devices positioned near or on aheating coil of the catheter. Once the temperature of the catheterexceeds 33° C., the flag is preferably removed. If at some point duringthe treatment of the patient the catheter temperature drops belowapproximately 25° C., the generator may raise the flag again.

At Block 708, the generator interface displays that the catheter deviceis properly connected to the generator. For instance, the interface maydisplay the message “DEVICE CONNECTED. VERIFY TEMPERATURE.” In certainembodiments, the message is displayed for approximately five seconds. AtBlock 708, the generator may also display the message “PRESS RF POWERBUTTON TO ENTER READY MODE.” In certain embodiments, an “RF ON” control(e.g., button) of the generator remains dark (e.g., not lit orhighlighted) until the catheter is ready to receive power from thegenerator.

At Block 710, the user inserts the catheter into the body of thepatient. At Block 712, the user activates the “RF ON” button on thegenerator to enable power delivery to the catheter. At Block 714, incertain embodiments, a start treatment message is displayed above the“RF ON” button, the “RF ON” button flashes green, and/or a message isdisplayed reading “PRESS HANDLE BUTTON OR START RF TREATMENT TO TREAT.”The generator interface may also indicate a total treatment time (suchas the cumulative time of treatment of a group of segments).

At Block 716, the user activates a control (e.g., a button) on thehandle of the treatment device or a start RF treatment button on thegenerator to begin the RF treatment. At Block 718, the catheterpreparation process 700 determines if the low temperature flag is raisedor if it has been lowered. Such a determination may advantageouslyindicate to the user if the catheter device has been inserted into thepatient's body. This may help to prevent unintentional delivery of powerwith the catheter device outside of the patient. If the low temperatureflag is not raised, the catheter preparation process 700 proceeds withBlock 720.

At Block 720, the generator initiates delivery of power to a therapeuticportion (e.g. a heating coil) of the catheter device. In certainembodiments, the generator also provides one or more indications to theuser that delivery of power has initiated. For instance, the “RF ON”button may turn white, the generator interface may display a “STOP RFTREATMENT” option, the generator may provide an audible tone,combinations of the same or the like. In certain embodiments, thegenerator then begins to ramp up the temperature of the catheter deviceto initiate treatment.

If at Block 718 the low temperature flag is raised, the catheterpreparation process 700 continues to Block 722. At Block 722, thegenerator interface displays “LOW TEMPERATURE. VERIFY DEVICE IS IN THEBODY-PRESS OK OR HANDLE BUTTON TO CLEAR AND START RF TREATMENT.” AtBlock 724, the catheter preparation process 700 determines if the “OK”button or the handle button has been pressed. If either button has beenpressed, the catheter preparation process 700 proceeds with Block 720.If neither button was pressed, the catheter preparation process 700continues with Block 726. At Block 726, the process 700 determines ifthe cancel button was pressed. If the cancel button was not pressed, thecatheter preparation process 700 returns to Block 722. If the cancelbutton was pressed, the process 700 returns to Block 716.

Once RF power is initiated, the catheter preparation process 700 movesto a Phase 1 process 730, an embodiment of which is illustrated in moredetail by the flowchart of FIG. 34B. In certain embodiments, thegenerator provides approximately forty watts of power to the catheterdevice for approximately six seconds during the Phase 1 process 730.

As illustrated, the Phase 1 process 730 begins with Block 732, whereinthe generator interface displays the message “DEVICE SHOULD REACH TARGETTEMPERATURE IN ‘X’ SECONDS,” wherein “X” represents a time limit suchas, for example, five seconds. In yet other embodiments, otherappropriate time limits may be used, such as, for example, ten seconds.

At Block 734, the Phase 1 process 730 determines if the temperature ofthe device has reached, for example, a set temperature of 120° C., 100°C. or 83% of the set temperature in less than three seconds. Forinstance, in certain preferred embodiments, the set temperature isgenerally attained within approximately 1.7 seconds after the initiationof power. If the indicated temperature has not been reached in theallotted time, the Phase 1 process 730 moves to Block 736, wherein thegenerator may issue an audible and/or visual alert. For instance, thegenerator display may show a message “ADVISORY: LOW TEMPERATURE, HIGHPOWER. ADJUST COMPRESSION.” In certain embodiments, the displayedmessage remains until the error condition is corrected.

At Block 734, if the temperature reaches the appropriate level withinthe allotted time, the Phase 1 process 730 continues with Block 738. AtBlock 738, the Phase 1 process 730 determines if the temperature of thedevice has reached the set temperature in less than, for example, sixseconds. If the temperature has not reached the set temperature in lessthan six seconds, the Phase 1 process 730 returns to Block 736.

If the temperature has reached the set temperature in less than sixseconds, the Phase 1 process 730 proceeds with Block 740. At Block 740,the generator interface displays the message “TARGET TEMPERATUREREACHED-VESSEL HEATING IN PROGRESS.” In certain embodiments, at thispoint, the generator issues a Phase 2 tone and maintains the current(e.g., set) temperature.

Returning to Block 736, once the error condition is cleared, the Phase 1process 730 moves to Block 742, wherein the generator determines if thetemperature of the catheter device has reached approximately 119° C.(approximately the set temperature) in less than six seconds. If so, thePhase 1 process 730 proceeds with Block 740.

If the catheter temperature has not reached the set temperature in theallotted amount of time, the Phase 1 process 730 proceeds with Block744. At Block 744, the RF power delivery is terminated. In certainembodiments, the generator may issue a termination beep and/or displaythe message “RF CYCLE STOPPED AT “X” SECONDS. TARGET TEMPERATURE NOTREACHED.” In certain embodiments, this message may remain until anygenerator key is pressed, the handle button is pressed, the RF treatmentis resumed at a new location, and/or after a ten-second time out. ThePhase 1 process 730 then returns to Block 714 of the catheterpreparation process 700.

After Block 740, the Phase 1 process 730 continues with a Phase 2process 750, an embodiment of which is illustrated in more detail by theflowchart of FIG. 34C. In certain embodiments, the generator reduces thepower output to the catheter device during the Phase 2 process 750,which preferably lasts for approximately fourteen seconds.

The Phase 2 process 750 begins at Block 752, wherein the process 750monitors (i) if the temperature of the catheter device drops below 118°C. (approximately the set temperature) for more than two seconds or (ii)if the power exceeds twenty-four watts for more than five seconds. Suchconditions may occur, for example, if there is too much fluid present inthe treatment region of the HAS (e.g., insufficient compression appliedto the patient's limb). In certain embodiments, such monitoring isperformed until the final five seconds of the Phase 2 process 750. Thus,such embodiments of the process 750 ignore temperature decreases and/orpower increases during the final five seconds of the treatment.

If either condition described in Block 752 does occur, the Phase 2process 750 proceeds with Block 754, wherein the generator interfacedisplays the message “ADVISORY: LOW TEMPERATURE, HIGH POWER. ADJUSTCOMPRESSION.” In certain embodiments, when such a condition iscorrected, the generator clears the warning message. Following Block754, or if neither of the specified conditions occurs at Block 752, thePhase 2 process 750 continues with Block 756. At Block 756, thegenerator provides an “end of cycle” alert (e.g., a beep). In addition,in certain embodiments, a message on the generator interface may read“PRESS HANDLE BUTTON OR START RF TREATMENT TO TREAT.” The Phase 2process 750 then returns to Block 714 of the catheter preparationprocess 700 to begin another treatment (e.g., a treatment of anothersection of the HAS).

FIGS. 34A-34C thus illustrate one embodiment of a method of treating ahollow anatomical structure, comprising: inserting a heat deliverydevice into a hollow anatomical structure; delivering power to the heatdelivery device during a temperature ramp-up phase; measuring timeelapsing during power delivery; monitoring operation of the heatdelivery device; and if the operation of the heat delivery device duringor shortly after said temperature ramp-up phase is acceptable,delivering power to the heat delivery device after said temperatureramp-up phase.

In variations of the method, the method further comprises: deliveringpower to the heat delivery device to reach a first treatmenttemperature; and delivering power to the heat delivery device to reach asubsequent second treatment temperature which is lower than said firsttreatment temperature.

In further variations of the method, the heat delivery device is anelectrically driven heating element, an electrode, or a laser. When theheat delivery device comprises an electrically driven heating element,an energy coupling surface of the heating element may have adistal-to-proximal length which is at least fifteen times the width ofthe heating element.

Further variations of the method additionally comprise measuring atemperature of at least one of (i) at least a portion of the heatdelivery device, and (ii) a portion of the hollow anatomical structurebeing treated. An example of this is shown in FIG. 34B in Blocks 734,738, and 742, which employ the temperature data measured. In anothervariation of the method, monitoring operation of the heat deliverydevice comprises determining whether the measured temperature reaches orexceeds a target temperature within a time limit. An example of this isshown in FIG. 34B in Block 738, in which the process checks whether thetemperature has reached a set temperature (in one variation, 120° C.).In another variation, monitoring operation of the heat delivery devicecomprises determining whether the measured temperature falls below atarget temperature within a time limit.

In a further variation, the method additionally comprises proceeding todeliver power to the heat delivery device after the temperature ramp-upphase only when the target temperature is reached or exceeded within thetime limit. An example of this is shown in Block 744 in FIG. 34B, inwhich the power to the heat delivery device is turned off when the settemperature is not reached within a period of six seconds.

In another variation of the method, monitoring operation of the heatdelivery device comprises comparing a measurement of electricalimpedance with a reference waveform.

A further variation of the method additionally comprises displaying aninstruction to adjust treatment of the hollow anatomical structure ifthe operation of said heat delivery device during said temperatureramp-up phase is not acceptable. In a further variation of this method,displaying an instruction to adjust treatment of said hollow anatomicalstructure comprises displaying an instruction to adjust the compressionof the hollow anatomical structure. An example of this is shown in FIG.34B in Block 736, in which a display indicates that compression shouldbe adjusted when the temperature has not reached 100° C. within threeseconds, or 83% of the set temperature.

In a variation of the method, the hollow anatomical structure is a vein.

Although the foregoing method of use has been described with referenceto particular embodiments, in other embodiments not all of the disclosedblocks need be performed, or additional blocks may be included. Forexample, different types of messages may be displayed on the generatorinterface and/or on a computer display coupled to the generator. In yetother embodiments, certain blocks may be combined into a single block,or one or more blocks may be subdivided into multiple blocks. In yetother embodiments, the blocks may be performed in a different order thanthe order described herein.

For example, in certain embodiments, the method of use described hereinfurther utilizes a process of detecting poor or non-uniform HAS fluidevacuation (e.g., exsanguination) and tissue contact with the heatingelement, such as can be achieved through external compression. Thedetection process may include detecting fluid evacuation and tissuecontact with the associated heating element by: measuring the ramp rateduring heating; comparing temperatures from multiple heat sensors alongthe heating element; and/or determining the heating element temperaturethrough RTD detection of temperature by impedance and then comparingthat temperature to the temperature measured by at least one heatsensor. Through such a detection process, the treatment system maydetect unfavorable conditions, such as, for example, the absence orrelease of external compression and/or a portion of the heating elementbeing positioned within an introducer sheath. In yet other embodiments,the thermal environment of the heating element may be detected throughproviding an initial power pulse to the heating element and thenmeasuring the rate of temperature decay. Such a characterization of thethermal environment may also advantageously be used to detect if theheating element is positioned outside the patient, such as during anaccidental start before the catheter has been properly inserted into theHAS.

In certain embodiments, a boiling sensor may also be integrated into thecatheter device, such as by providing at least two electrodes on theexterior of the catheter and then measuring the resistance to currentflow between the two electrodes (e.g., to indicate an air gap). In suchembodiments, the power delivered by the generator may be adjustedrelative to the indication of boiling, such as by reducing the deliveredpower when boiling occurs.

It will also be understood that, in certain embodiments, one or moreblocks of the flowcharts illustrated in FIGS. 34A-34C may be implementedby computer program instructions. For instance, the computer programinstructions may be provided to a processor of the RF generator or othertreatment device power source, a general purpose computer, specialpurpose computer, or other programmable data processing apparatus, suchthat the instructions, which execute via the processor of the RFgenerator, power source, computer or other programmable data processingapparatus, create means for implementing the acts specified in theflowchart blocks. In certain embodiments, the blocks may be executed byone or more modules that comprise logic embodied in hardware or firmwareof the RF generator, computer, etc., or in software stored in the RFgenerator, power source, computer, etc. It will be further appreciatedthat hardware modules may comprise connected logic units, such as gatesand flip-flops, and/or may comprise programmable units, such asprogrammable gate arrays or processors.

The computer program instructions may also be stored in acomputer-readable medium that can direct the RF generator, power source,a computer or other programmable data processing apparatus to operate ina particular manner, such that the instructions stored in thecomputer-readable medium produce an article of manufacture includinginstruction means which implement the acts specified in the flowchartblocks.

FIGS. 34A-B thus illustrate one embodiment of a method of facilitatingthe treatment of a hollow anatomical structure. The method involves (A)initiating power delivery to an energy application device of a hollowanatomical structure treatment device; (B) measuring an operatingparameter of the treatment device, the operating parameter beingrelevant to energy coupling between the energy application device andits surroundings; (C) determining whether the operating parametersatisfies a first energy coupling condition within a first time intervalfollowing the initiating; and (D) if the operating parameter does notsatisfy the first energy coupling condition within the first timeinterval, providing a warning.

In variations of this method of facilitating treatment, the measuredoperating parameter can be any one or combination of the following: thetemperature of at least a portion of the treatment device; thetemperature of at least a portion of the energy application device;and/or the power delivered to the energy application device. Where poweris delivered to the energy application device by electric current, themeasured operating parameter can be any one or combination of thefollowing: the electrical power delivered to the energy applicationdevice; the magnitude of the electric current delivered to the energyapplication device; and/or the electrical impedance of the energyapplication device. Where power is delivered to the energy applicationdevice by electric current, the energy application device can comprise aconducting coil.

In further variations of this method of facilitating treatment, wherethe measured operating parameter is the temperature of at least aportion of the energy application device, the first energy couplingcondition can comprise meeting or exceeding a first target temperaturevalue for the temperature of at least a portion of the energyapplication device; or meeting or exceeding the first target temperaturevalue within a prescribed period of time after initiating powerdelivery. In FIG. 34B, examples of this are shown in Block 734, wherethe process checks for a target temperature (100 degrees C.) within aprescribed time period (3 seconds) after initiation of power delivery;in Block 738, where the process checks for a different targettemperature (the “set” temperature which can be a desired treatmenttemperature; in this case, 120 degrees C.) within a prescribed timeperiod (6 seconds) after initiation of power delivery; and in Block 742,where the process checks for a different target temperature(approximately the set temperature) within a prescribed time period (6seconds) after initiation of power delivery.

In further variations of this method of facilitating treatment, wherethe measured operating parameter is the temperature of at least aportion of the energy application device, the first energy couplingcondition can comprise the absence of sudden, relatively large changesto the temperature of at least a portion of the energy applicationdevice. This particular variation provides a method of or involvingdetecting sudden insufficient compression of the portion of the HAS inwhich the energy application device is positioned (or detecting theremoval of compression of the HAS), which increases fluid flow aroundthe energy application device and thereby drains heat from the energyapplication device.

In further variations of this method of facilitating treatment, wherethe measured operating parameter is the power delivered to the energyapplication device, the first energy coupling condition can comprise adelivered power magnitude which is substantially similar to a referencewaveform of expected power magnitude; and/or a rate of change of themagnitude of power delivered to the energy application device which issubstantially similar to a reference waveform of expected powerdelivered after achievement of a target temperature value. To implementchecking for these energy coupling conditions, a reference waveform(indicating magnitude vs. time) of expected power magnitude can bestored in memory accessible to the power source (e.g. RF generator)processor. The delivered power magnitude, and/or a rate of changethereof, can be monitored, either continuously, intermittently, or atselected “checkpoints,” and compared to the reference waveform.Substantial similarity (e.g. deviating no more than 1%, 5%, or 10% atany point, in various embodiments) to the reference waveform indicatesnormal power-up or operation of the energy application device. In thevariation where the energy coupling condition is a delivered powermagnitude substantially similar to the reference waveform, thisparticular variation provides a method of or involving detectingpower-up of the energy application device in air, the absence orinsufficiency of local HAS compression at the initiation of powerdelivery, and/or the absence or insufficiency of local HAS compressionlater during power delivery, as these conditions are associated withimproper delivered power magnitude. In the variation where the energycoupling condition is a rate of change of delivered power magnitudesubstantially similar to the reference waveform, this particularvariation provides a method of or involving detecting removal orinsufficiency of local HAS compression, and/or movement of the energyapplication device during heating, as these conditions are associatedwith improper delivered power magnitude.

In further variations of this method of facilitating treatment, wherethe measured operating parameter is the electric current delivered tothe energy application device, the first energy coupling condition cancomprise a delivered electric current magnitude which is substantiallysimilar to a reference waveform of expected electric current magnitude;and/or a rate of change of the magnitude of electric current deliveredto the energy application device which is substantially similar to areference waveform of expected electric current delivered afterachievement of a target temperature value. To implement checking forthese energy coupling conditions, a reference waveform (indicatingmagnitude vs. time) of expected electric current magnitude can be storedin memory accessible to the power source (e.g. RF generator) processor.The delivered electric current magnitude, and/or a rate of changethereof, can be monitored, either continuously, intermittently, or atselected “checkpoints,” and compared to the reference waveform.Substantial similarity (e.g. deviating no more than 1%, 5%, or 10% atany point, in various embodiments) to the reference waveform indicatesnormal power-up or operation of the energy application device.

In further variations of this method of facilitating treatment, wherethe measured operating parameter is the electrical impedance of theenergy application device, the first energy coupling condition comprisesa measured electrical impedance magnitude which is substantially similarto a reference waveform of expected electrical impedance of the energyapplication device; and/or a measured rate of change of the magnitude ofthe electrical impedance of the energy application device which issubstantially similar to a reference waveform of expected electricalimpedance of the energy application device. To implement checking forthese energy coupling conditions, a reference waveform (indicatingmagnitude vs. time) of expected electrical impedance magnitude can bestored in memory accessible to the power source (e.g. RF generator)processor. The electrical impedance magnitude, and/or a rate of changethereof, can be monitored, either continuously, intermittently, or atselected “checkpoints,” and compared to the reference waveform.Substantial similarity (e.g. deviating no more than 1%, 5%, or 10% atany point, in various embodiments) to the reference waveform indicatesnormal power-up or operation of the energy application device.

In further variations of this method of facilitating treatment, if theoperating parameter does not satisfy the first energy coupling conditionwithin the first time interval, power delivery to the energy applicationdevice is reduced or terminated. In FIG. 34B, examples of this are shownin Block 734, where failure to satisfy the first energy couplingcondition (temperature above 100 degrees C.) during a time interval(within 3 seconds after initiation of power delivery) can lead to powershutdown in Block 744; and in Blocks 738 and 742, which also set forthenergy coupling conditions (target temperatures) and time intervals(within 6 seconds after initiation of power delivery), wherein failureto satisfy the coupling condition in the specified time can also lead topower shutdown in Block 744.

In further variations of this method of facilitating treatment, thewarning provided (if the measured operating parameter does not satisfythe first energy coupling condition within the first time interval)comprises a message to adjust the environment of the hollow anatomicalstructure treatment device within the patient. Examples of this areshown in Blocks 736 and 754. Accordingly, one variation of the messagecan instruct a user to adjust or improve compression of the portion ofthe hollow anatomical structure containing the treatment device.

Further variations of this method of facilitating treatment can alsoinvolve: determining whether the operating parameter satisfies a secondenergy coupling condition within a second time interval following thefirst time interval; and, if the operating parameter does not satisfythe second energy coupling condition within the second time interval,providing a warning. Examples of this are shown in Blocks 738, 742 and752. Still further variations of this method can also involveterminating or reducing power delivery to the energy application deviceif the operating parameter does not satisfy the second energy couplingcondition within the second time interval. An example of this is shownin Block 744.

Further variations of this method of facilitating treatment can alsoinvolve taking corrective measures such as any one or more of thefollowing: applying compression in the vicinity of the hollow anatomicalstructure containing the energy application device; adjusting thelocation or force of existing compression in the vicinity of the hollowanatomical structure containing the energy application device; and/orverifying effective occlusion of flow within the hollow anatomicalstructure in the vicinity of the energy application device.

In further variations of this method of facilitating treatment, theenergy application device comprises a resistance temperature device; themethod further comprises computing a temperature of the energyapplication device based on the electrical impedance of the energyapplication device; and the first energy coupling condition comprisescorrelation of the measured temperature of the energy application deviceto the computed temperature of the energy application device. Thisparticular variation provides a method of or involving detecting thepresence of non-uniform temperature of the energy application device,and/or detecting non-uniform or inadequate local HAS compression, asthese conditions are associated with lack of correlation betweenmeasured temperature and computed temperature of the energy applicationdevice.

In view of FIGS. 34A-B and the disclosure of treatment devices such asthe catheters 202, 202′, 900 and 950, one embodiment of apparatus foruse in treating a hollow anatomical structure comprises: (A) an energyapplication device adapted to receive power from a power source; (B) ameasuring device that measures an operating parameter of the energyapplication device, the operating parameter being relevant to energycoupling between the energy application device and its surroundings; (C)a module in communication with the measuring device, the moduleconfigured to determine whether the operating parameter satisfies afirst energy coupling condition within a first time interval followingthe initiation of power delivery to the energy application device; and(D) a warning device in communication with the module, the modulefurther configured to cause the warning device to provide a warning ifthe operating parameter does not satisfy the first energy couplingcondition within the first time interval.

In various embodiments, the energy application device can comprise anyof the heating elements, electrodes, therapeutic devices, etc. disclosedherein, including but not limited to the resistive element 14, theheating element 208, or therapeutic element 280; or a laser,fluid-conducting heat exchanger, chemical reaction chamber or any otherdevice suitable to impart energy to an HAS. The measuring device cancomprise a thermocouple, a thermistor, an RTD (which can be the energyapplication device itself where the energy application device is anelectrically driven coil or other electrically driven heating element),a photodetector, an ammeter, ohm meter, volt meter; or hardware orsoftware components of the treatment power source, RF generator,computer, etc. The module can comprise hardware such as a treatmentpower source, RF generator, computer, etc., or software executing on anyof these devices, or firmware, or a combination of hardware, softwareand/or firmware.

FIG. 34A thus illustrates one embodiment of a method comprising: (A)sensing a temperature on or near at least a portion of a heatapplication device of a hollow anatomical structure treatment device;(B) determining whether the temperature satisfies a required initialtemperature condition; (C) receiving a request to initiate powerdelivery to the heat application device of the hollow anatomicalstructure treatment device; and (D) if the temperature does not satisfythe required initial temperature condition, performing a safetyprocedure to interrupt a normal power-up process for the heatapplication device.

As one example of determining whether the sensed temperature satisfies arequired initial temperature condition, in Block 718 the process checksfor the presence of a low temperature flag, which remains raised untilthe required initial temperature condition (in this case, having senseda temperature above 33 degrees C. since the catheter was plugged in,and/or currently sensing a temperature above 33 degrees C.) has beensatisfied. As examples of receiving a request to initiate powerdelivery, Block 716 mentions two alternatives: sensing the press of apower activation button on the catheter handle, or sensing the press ofa Start RF Treatment button or “softkey” on the power source. As anexample of performing a safety procedure, Blocks 722-726 show thedisabling of therapeutic power delivery start-up, the display of a lowtemperature warning and prompt for the user to insert (or verifyinsertion of) the energy application device, and the actions to be takenif the user presses the power activation button on the catheter or powersource, or a cancel button.

One variation of this method involves allowing a normal power-up processfor the heat application device to proceed, if the sensed temperaturesatisfies the required initial temperature condition. One example ofthis is shown in Blocks 718-720, wherein device power-up proceeds if thelow temperature flag is not raised.

In another variation of this method, determining whether the temperaturesatisfies a required initial temperature condition comprises determiningwhether the temperature has satisfied the required initial temperaturecondition at any time during a temperature sensing period. Thetemperature sensing period can begin after connection of the treatmentdevice to a power source (Block 704), and/or end before delivery oftherapeutic energy from the power source to the treatment device (Block720).

In further variations of this method, the safety procedure can comprisepreventing the initiation of power delivery to the heat applicationdevice (e.g., Blocks 722-724), and/or ceasing the delivery of power tothe heat application device.

In further variations of this method, the required initial temperaturecondition can be that the sensed temperature meet or exceed a minimumtemperature. The minimum temperature can be any one or more of:significantly above an expected ambient room temperature; substantiallyat an expected internal temperature of the hollow anatomical structureto be treated with the treatment device; and/or 5 to 10 degrees Celsiuslower than the normal physiologic internal temperature of a hollowanatomical structure of the type normally treated with the treatmentdevice.

In further variations of this method, the required initial temperaturecondition can be that the sensed temperature fall within an acceptabletemperature range. The acceptable temperature range can be any one ormore of: significantly above an expected ambient room temperature;bracketing an expected internal temperature of the hollow anatomicalstructure to be treated with the treatment device; and/or bracketing atemperature which is 5 to 10 degrees Celsius lower than the normalphysiologic internal temperature of a hollow anatomical structure of thetype normally treated with the treatment device.

Further variations of this method comprise providing a warning if thesensed temperature does not satisfy the required initial temperaturecondition. One example of this is seen in Block 722.

Further variations of this method comprise verifying that the heatapplication device is properly disposed within a hollow anatomicalstructure of a patient; and manually overriding the safety procedure andinitiating a power-up process for the heat application device. Oneexample of this is seen in Block 724.

In view of FIGS. 34A-B and the disclosure of treatment devices such asthe catheters 202, 202′, 900 and 950, one embodiment of apparatus foruse in treating a hollow anatomical structure comprises: (A) a heatapplication device adapted to receive power from a power source; (B) auser interface adapted to receive a request from a user to initiatepower delivery to the heat application device; (C) a temperaturemeasuring device for measuring a temperature within or near the heatapplication device; (D) a module in communication with the temperaturemeasuring device and the user interface, the module configured todetermine whether a temperature measured by the temperature measuringdevice satisfies a required initial temperature condition; wherein themodule is further configured to follow a safety procedure to interrupt anormal power-up process for the heat application device if thetemperature measured by the temperature measuring device does notsatisfy the required initial temperature condition.

In various embodiments, the heat application device can comprise any ofthe heating elements, electrodes, therapeutic devices, etc. disclosedherein, including but not limited to the resistive element 14, theheating element 208, or therapeutic element 280; or a laser,fluid-conducting heat exchanger, chemical reaction chamber or any otherdevice suitable to impart heat energy to an HAS. The temperaturemeasuring device can comprise a thermocouple, a thermistor, an RTD(which can be the energy application device itself where the energyapplication device is an electrically driven coil or other electricallydriven heating element), or a photodetector; or hardware or softwarecomponents of the treatment power source, RF generator, computer, etc.The module can comprise hardware such as a treatment power source, RFgenerator, computer, etc., or software executing on any of thesedevices, or firmware, or a combination of hardware, software and/orfirmware.

FIG. 35 illustrates a graph 800 of exemplary embodiments of power, time,and temperature measurements that may be encountered during thetreatment of a HAS of a patient. As illustrated, the x-axis of the graph800 plots a time (in seconds) of the treatment process. The left y-axisof the graph 800 displays the temperature values of the catheter (in °C.) and power values of the generator (in Watts). The right y-axis ofthe graph 800 illustrates the impedance values of the heating element ofthe catheter device (in Ohms) throughout the treatment.

As can be seen, the graph 800 comprises a temperature curve 802, a powercurve 804 and an impedance curve 806 that each depicts measurementsduring five treatments of a patient. In particular, the graph 800illustrates a treatment that initiates approximately at a time 20seconds. At this point, the power delivered by the generator is rampedup to forty Watts, which causes a corresponding increase in thetemperature of the catheter device (e.g., to approximately 120° C.). Incertain embodiments, the catheter device reaches a target temperature ofapproximately 120° C. about 1.7 seconds after the power delivery isinitiated.

After approximately six seconds, the power delivered by the generator isreduced to twenty-five Watts, while the temperature of the deviceremains at approximately 120° for approximately fourteen more seconds.Thus, the graph 800 illustrates, for example, that to maintain a targettemperature of 120°, the generator need not maintain a constant poweroutput of 40 watts once the catheter device has reached the set (target)temperature. As can also be seen from the graph 800, the impedance ofthe catheter device has a direct relationship to the device temperature.That is, as the temperature of the catheter device (e.g., heating coil)increases, so does the impedance of the catheter device. In certainembodiments, the graph 800 is indicative of a use of a catheter devicehaving a heating coil made of Alloy 52.

The graph 800 also illustrates a double treatment of the first portionof a HAS, which is shown by reference numeral 810. In particular, thedouble treatment includes a re-application of power at a time ofapproximately 45 seconds such that the temperature of the catheterdevice does not cool to body temperature between successive treatments.Rather, the temperature of the catheter device drops to approximately65° C., at which point power delivery is re-initiated. The temperatureof the catheter device increases again to approximately 120° C. Thegraph 800 also illustrates a third treatment 820, a fourth treatment830, and a fifth treatment 840. In certain embodiments, the thirdthrough fifth treatments 820, 830 and 840 correspond to treatments indifferent segments of the target HAS.

Accordingly, the graph 800 can be considered to depict a method oftreating an HAS in which multiple treatments are administered to theHAS. The first treatment 810 is performed at the distal-most treatmentlocation within the HAS, and the second through fourth treatments 820,830, 840 are performed at successively more proximal locations, as thecatheter is moved proximally between each treatment. As depicted, thefirst treatment 810 can involve applying energy to the first treatmentlocation in the HAS at two (or more) distinct times, and the subsequenttreatments 820, 830, 840, etc. can involve applying energy to thesubsequent treatment locations within the HAS only once. Alternatively,multiple distinct energy applications can be employed in any one or moreof the subsequent treatments. Whether one or multiple energyapplications are employed in the first treatment 810 (or in thesubsequent treatments 820, 830, 840), in certain embodiments, thetreatment method depicted by the graph 800 can comprise applying energyto the first treatment location in the HAS (in the first treatment 810)for a longer total duration than to any one of the subsequent treatmentlocations (in the subsequent treatments 820, 830, 840). This can be donein treatment situations where the HAS has a larger cross-sectionalprofile, as viewed along a longitudinal axis of the HAS, in the firsttreatment location than in any one of the subsequent treatmentlocations. Such a situation is often encountered when treating the GSVas depicted in FIGS. 16A-16D, when the catheter is drawn proximally fromthe SFJ as the treatment progresses. In this type of GSV treatment, thefirst treatment location (the site of the first treatment 810) is closerto the SFJ than is any of the subsequent treatment locations.

FIG. 36A illustrates an embodiment of a catheter system 900 usable totreat a HAS of a patient, such as, for example, according to thetreatment methods described herein. The catheter system 900 includes aheating element 910, which may comprise any of the heating elements ortherapeutic elements described herein. Thus, in various embodiments, theheating element 910 can comprise any of the devices disclosed herein assuitable for use as the resistive element 14, heating element 208 or thetherapeutic element 280. The catheter system 900 also includes indexingmarks 912 to assist in the positioning of the heating element 910 duringsuccessive treatments of the patient. Warning lines 914 are alsoincluded on the catheter shaft to indicate to a user the last treatmentof the catheter (e.g., to prevent power delivery while the heatingelement is in an introducer sheath). The catheter system 900 alsoincludes adjustable markers 916 and a strain relief 920.

As is further depicted in FIG. 36A, a luer adaptor 922 is positioned onthe proximal end of the catheter system 900. In certain embodiments, theluer adaptor is in fluid communication with an internal lumen of thecatheter, allowing for delivery of fluid and/or passage of a guidewire.The system 900 further includes an integrated cable 924 with aninstrument cable connector 926 that couples to a generator, such as oneof the RF generators disclosed herein.

FIG. 36B illustrates a catheter system 950 similar to the cathetersystem 900 of FIG. 36A. The catheter system 950 includes a heatingelement 960, indexing marks 962, and warning lines 964 to indicate thefinal treatment section of the catheter. In various embodiments, theheating element 960 can comprise any of the devices disclosed herein assuitable for use as the resistive element 14, heating elements 208 or910, or the therapeutic element 280. The catheter system 950 alsoincludes adjustable markers 966, a strain relief 970, a luer adaptor972, an integrated cable 974, and an instrument cable connector 976. Thecatheter system 950 further includes a start/stop switch 980. In certainembodiments, the start/stop switch 980 allows a user to control thedelivery of RF power to the heating element 960 without having toactivate a control on an associated RF generator.

In certain embodiments, it may also be advantageous to limit the numberof times that a catheter device is clinically used. For example, one ormore methods may be employed by which the power generator detects howmany times a catheter has been used. For instance, in certainembodiments, the catheter device may incorporate a smart electronicsignature or a radio frequency identification (RFID) tag (such as, forexample, in the handle). In other embodiments, the catheter device maycomprise an identifying resistor with a fuse that is shorted by theinitial energy delivery. In such embodiments, the generator and/orcomputing device associated therewith may maintain in memory data thatidentifies that an unused device has been used for the first time andthat allows the device (a used device) to be used for a particularperiod of time.

Except as further described herein, any of the catheters disclosedherein may, in some embodiments, be similar to any of the cathetersdescribed in U.S. Pat. No. 6,401,719, issued Jun. 11, 2002, entitled“METHOD OF LIGATING HOLLOW ANATOMICAL STRUCTURES;” or in U.S. Pat. No.6,179,832, issued Jan. 30, 2001, titled “EXPANDABLE CATHETER HAVING TWOSETS OF ELECTRODES;” or in U.S. patent application Ser. No. 11/222,069,filed Sep. 8, 2005, entitled “METHODS AND APPARATUS FOR TREATMENT OFHOLLOW ANATOMICAL STRUCTURES.” In addition, any of the cathetersdisclosed herein may, in certain embodiments, be employed in practicingany of the methods disclosed in the above-mentioned U.S. Pat. No.6,401,719 or 6,179,832, or the above-mentioned U.S. patent applicationSer. No. 11/222,069 filed Sep. 8, 2005. The entirety of each of thesepatents and application is hereby incorporated by reference herein andmade a part of this specification.

For exemplary purposes, a method of treatment will now be described withreference to embodiments of the treatment systems described herein. Incertain preferred embodiments, the treatment method comprisesendovascular vein treatment using a catheter with an integrated heatingelement. The description of the treatment method will be divided intothree stages: a patient preparation stage; a treatment stage and afollow-up stage. A skilled artisan will recognize that the threedifferent stages are for reference purposes only and that, in otherembodiments, the acts described hereinafter may occur in differentstages, in more than one stage, and/or in a different order.

The treatment method begins with the patient preparation stage. Duringthis initial stage, a mapping of the veins intended for treatment isperformed. For instance, duplex ultrasound (DU) imaging or other likemethods may be used to map the vessels. In certain embodiments, themapping includes recording the diameters of the veins for treatment. Incertain embodiments, mapping further includes noting the GSV track anddepth, locations of significant tributaries, aneurysmal segments and/orpotential vein access sites. An indelible marker may also be used torecord particular landmarks on the surface of the patient's skin. Incertain embodiments, the mapping is performed on the same day as theactual vein treatment or may be performed prior to the treatment day.

Following mapping, a local anesthetic is optionally administered at thevein access site. In certain embodiments, a mild sedation may also begiven to the patient. In certain embodiments, it is also advantageous toavoid during this initial stage certain factors (e.g., certain drugs, acold environment, patient anxiety, combinations of the same or the like)that may induce venospasm, which may hinder the ability to access thetarget vein.

The patient is then preferably positioned to facilitate vein access,such as by positioning the patient so as to increase the diameter of thetarget vein. For example, the patient's legs may be positioned below thelevel of the patient's heart. As discussed in more detail below, priorto and/or during treatment, the patient's legs may then be moved to ahorizontal position or preferably above the level of the patient's heartto assist in reducing vein diameter and/or reduce venous filling.

In certain embodiments, the physician accesses the target vein via apercutaneous stick using, for example, an 18 gauge (thin-walled) or a 19gauge ultra thin-walled needle or via a small cut-down. The physicianthen inserts an introducer sheath, such as, for example, a seven-Frenchintroducer sheath with an eleven-centimeter length, into the patient.

Prior to insertion of the catheter into the sheath, the inner lumen ofthe catheter is preferably flushed with a heparinized saline. The lumenis then capped, and the outer surface of the catheter is wiped withsaline, heparinized saline or other like solution. Once the catheter isprepared and the introducer sheath is properly positioned, the catheteris placed into the introducer sheath, and the catheter tip is advancedto a point for treating the target vein.

For example, in certain embodiments, the catheter may be advanced to thesaphenofemoral junction (SFJ), the tip of the catheter being initiallypositioned just inferior to the ostium of the superficial epigastricvein or, alternatively, one to two centimeters distal to the SFJ. Incertain embodiments, catheter navigation to the treatment site may beperformed using ultrasound guidance, palpation, and/or with a guidewire.For example, a 0.025 inch guidewire with a 150 or 260 centimeter lengthmay be used to navigate the catheter through the patient's venousanatomy. It may also be advantageous to avoid advancing the catheteragainst resistance from the vein so as to avoid vein perforation.

Following placement of the catheter, a local anesthetic may beoptionally administered, which may preferably include perivenoustumescent anesthesia along the vein segment to be treated. Inembodiments in which the target vein is located near the skin surface(e.g., less than one centimeter below the skin surface), a sufficientsubcutaneous distance between the vein and skin may be created bytumescent infiltration of saline or dilute local anesthetic solution.For instance, a 20 or 22 gauge, 3.5 inch long spinal needle may be usedfor the tumescent fluid infiltration.

In certain embodiments, the treatment method further includes using atumescent infiltration of dilute local anesthetic or saline into theperivascular space to create a circumferential fluid layer around thevessel to be treated. For instance, a sufficient volume of the fluid maybe used to exsanguinate and/or compress the vein to achieve appositionof the catheter heating element and the vein wall. For example, thephysician may confirm that the vein has been adequately compressed andthat the tumescent solution has infiltrated circumferentially around thevein by scanning the entire treatment length with DU imaging.

In certain embodiments, the patient is advantageously placed in theTrendelenburg position so that the leg with the target vein is above theheart to facilitate vein collapse, apposition, and/or exsanguination. Inone embodiment, the treatment method further includes partiallywithdrawing the introducer sheath until the sheath hub and nearestcatheter index line are aligned, while also maintaining the catheter tipposition. The physician then secures the introducer sheath to the skinof the patient. In another embodiment, a position datum is created inalignment with a catheter index line, such as by drawing a line orplacing a piece of tape on the patient's skin.

In certain embodiments, the initial preparation stage of the treatmentmethod includes verifying the position of the catheter tip using DUimaging or another appropriate method. For instance, the physician mayverify that the heating element of the catheter is not positioned in thedeep venous system. If a guidewire was used to advance the catheterwithin the venous system, the guidewire may then be removed.

The treatment stage follows the patient preparation stage. To begin thetreatment stage, and prior to energy delivery, the physician preferablycreates firm contact between the target vein wall and the heatingelement by compressing the HAS segment to be treated. For example, incertain embodiments, the physician may manually apply pressure to thepatient's leg in order to create the desired contact. In otherembodiments, the physician may wrap the patient's leg with anelastomeric wrap (e.g., an Esmark bandage) to create the desired contactalong the full length of the catheter. The treatment method may alsoadvantageously comprise creating a near-bloodless field for the catheterwith little or no blood flow past the heating element.

To obtain the near-bloodless field, the physician may perform perivenoustumescent infiltration along with at least two of the following: (1)exerting external compression along the length of the heating element;(2) tightly wrapping the limb, such as, for example, with an Esmarkbandage; and (3) further positioning the legs of the patient above theheart to facilitate vein collapse, apposition and/or exsanguination. Incertain embodiments, the wrapping act need not be performed if asufficient volume of tumescent infiltration is used to exsanguinate thevein and obtain apposition of the vein wall and catheter heatingelement.

The physician then enables RF energy delivery by activating anappropriate control (e.g., an “RF POWER” button) on the RF generator. Incertain embodiments, the generator includes an indicator (such as avisual and/or audible indicator) to alert the physician that thegenerator is ready to deliver energy. For instance, the generator mayinclude an RF control (e.g., an “RF POWER” button) that blinks whenenergy delivery is enabled. In certain further embodiments, if an errorcondition prevents energy delivery from being enabled, the generator mayfurther display an error message, such as on a screen or like userinterface.

Once energy delivery is enabled, the physician initiates energy deliveryby activating the appropriate generator control (e.g., pressing a “StartRF” control on the generator) and/or activating a control on thecatheter handle (e.g., an optional “START/STOP” button on the handle).RF energy delivery may be automatically terminated by the generator whenthe treatment cycle is complete, or alternatively the physician mayterminate energy delivery earlier by pressing the appropriate control(s)on the generator and/or catheter handle.

Furthermore, in certain embodiments, the target vein is advantageouslycompressed onto the full length, or substantially full length, of theheating element during application of energy so as to avoid inconsistenteffectiveness and/or possible failure by the catheter.

In certain embodiments, if a certain temperature is not reached within apredetermined period of time (e.g., six seconds) after initiation of theRF energy delivery, the treatment method includes terminating the RFenergy delivery, verifying the effectiveness of flow occlusion andproper tip position, and re-initiating treatment of the HAS segment. Insuch embodiments, the inability to reach the set temperature within thepredetermined period of time may indicate that fluid flow or presence offluid within the vein is cooling the treatment segment. Furthermore,continuous temperature readings below the set temperature may result inincomplete treatment. If such occurs, the treatment method may includestopping the treatment, reconfirming vessel apposition to the catheterheating element, reconfirming the absence of blood flow in the vesselsegment to be treated, applying more firm external compression ifneeded, and then retreating the HAS segment.

Following the treatment time interval, the RF energy delivery terminatesautomatically. The RF energy delivery may then optionally be repeated ina given vein segment according to the treatment procedures by thephysician. Double-treatment, or multiple treatments, of a vein segmentmay be desirable at the first treatment nearest the SFJ, within ananeurismal vein segment, or near a large sidebranch vessel. In certainembodiments of the treatment method, it is preferable that the catheteris not re-advanced through an acutely treated vein segment.

In certain embodiments, the RF energy delivery may result in a targettreatment temperature between approximately 100° C. and approximately120° C. (e.g., 100° C., 110° C., or 120° C.). The treatment time pervein segment may have a duration of approximately ten seconds toapproximately thirty seconds (e.g., 10, 15, 20, 25, or 30 secondintervals). In certain preferred embodiments, a seven-centimeter veinsegment is treated at approximately 120° C. for approximately twentyseconds. Moreover, a 45-centimeter vein may be treated in approximatelythree to five minutes.

After treatment of a particular segment is completed, the treatmentmethod comprises quickly withdrawing the catheter until the next visibletreatment index line is aligned with the hub of the introducer sheath orother established datum. During such withdrawal of the catheter, somefriction may exist between the vein wall and catheter after a heatingcycle.

Once the catheter is re-positioned appropriately, the next vein segmentis treated in a manner similar to the treatment of the first section.This process is repeated until all the vein segments are treated. Incertain embodiments, diagonal lines on the catheter shaft are used toindicate the last full treatment segment (e.g., when the lines arevisible outside the introducer sheath). In certain embodiments, it isalso advantageous to confirm that the heating element is in the veinbefore the last treatment in order to avoid energy delivery while theheating element is inside the introducer sheath.

In certain embodiments, the treatment method further comprisesevaluating the treated vein segments to analyze the treatment outcome.For example, the physician may utilize ultrasound or other means todetermine the extent of the treatment of the vein by observing forreduced vein inner diameter, thickening of the vein wall, and absence ofblood flow or refluxing blood flow.

When terminating the treatment stage, the physician disables RF energydelivery by deactivating the appropriate control on the RF generator(e.g., an “RF POWER” button), withdrawing the catheter, removing theexternal compression, and obtaining hemostasis at the access site.

After the treatment stage, the treatment process includes a follow-upstage that comprises acts directed to facilitating and/or expeditingpatient recovery. The follow-up stage may include instructing thepatient to ambulate frequently and/or to refrain from strenuousactivities or heavy lifting for several days. Post-operative compressionof the target limb is also recommended for at least one week followingthe treatment.

In certain embodiments of the treatment process, a follow-up examinationis conducted within 72 hours of the treatment. Such an examination maypreferably include an assessment to ensure that there is no thrombusextension into deep veins.

Although the foregoing treatment process has been with respect toparticular embodiments, in other embodiments, the acts described hereinmay be combined, performed in a different order, and/or may be omittedfrom the treatment process. Furthermore, in certain embodiments,additional acts may be included in the treatment process in order toassist in the treatment and/or recovery of the patient.

Additional embodiments comprise methods of sterilization. Certain suchmethods can comprise sterilizing, either terminally or sub-terminally,any of the apparatus disclosed herein that are intended for insertioninto (or other contact with) the patient or that are intended for use ator near the surgical field during treatment of a patient. Any suitablemethod of sterilization, whether presently known or later developed, canbe employed.

Accordingly, certain methods comprise sterilizing, either terminally orsub-terminally, any one or combination of the following apparatus: theresistive element systems 10, 20 (with or without a working end of thetypes depicted in FIGS. 4, 5-7A, 7C-7E, and 8-13B) and/or the catheters11, 21 or sheath 22 thereof; the HAS treatment system 200 and/or thecatheters 202, 202′ or introducer sheath 204 thereof; the datum devices230, 250 (with or without a corresponding sheath 234/254 attachedthereto); the HAS indexing treatment device 270 and/or the catheter 272,introducer hub 274 or outer sheath 277 thereof; the catheter shaft 290with markings 292; the catheter 304 with detents 302; the HAS treatmentsystem 310 and/or the catheter shaft 314 thereof; the HAS treatmentsystem 330; the indexing devices 350, 360, 370, 390; the indexing system430; the catheter handle 460; the catheter systems 900 and 950. Anysuitable method of sterilization, whether presently known or laterdeveloped, can be employed. For example, the method can comprisesterilizing any of the above-listed apparatus with an effective dose ofa sterilant such as cyclodextrin (Cidex™), ethylene oxide (EtO), steam,hydrogen peroxide vapor, electron beam (E-beam), gamma irradiation,x-rays, or any combination of these sterilants.

The sterilization methods can be performed on the apparatus in questionwhile the apparatus is partially or completely assembled (or partiallyor completely disassembled); thus, the methods can further comprisepartially or completely assembling (or partially or completelydisassembling) the apparatus before applying a dose of the selectedsterilant(s). The sterilization methods can also optionally compriseapplying one or more biological or chemical indicators to the apparatusbefore exposing the apparatus to the sterilant(s), and assessingmortality or reaction state of the indicator(s) after exposure. As afurther option, the sterilization methods can involve monitoringrelevant parameters in a sterilization chamber containing the apparatus,such as sterilant concentration, relative humidity, pressure, and/orapparatus temperature.

In view of the foregoing discussion of methods of sterilization, furtherembodiments comprise sterile apparatus. Sterile apparatus can compriseany of the apparatus disclosed herein that are intended for insertioninto (or other contact with) the patient or that are intended for use ator near the surgical field during treatment of a patient. Morespecifically, any one or combination of the following can be provided asa sterile apparatus: the resistive element systems 10, 20 (with orwithout a working end of the types depicted in FIGS. 5-7A, 7C-7E, and8-13B) and/or the catheters 11, 21 or sheath 22 thereof; the HAStreatment system 200 and/or the catheters 202, 202′, 202″ or introducersheath 204 thereof; the datum devices 230, 250 (with or without acorresponding sheath 234/254 attached thereto); the HAS indexingtreatment device 270 and/or the catheter 272, introducer hub 274 orouter sheath 277 thereof; the catheter shaft 290 with markings 292; thecatheter 304 with detents 302; the HAS treatment system 310 and/or thecatheter shaft 314 thereof; the HAS treatment system 330; the indexingdevices 350, 360, 370, 390; the indexing system 430; the catheter handle460.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of the disclosure. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms; furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made without departing from the spiritof the disclosure.

A number of applications, publications and external documents areincorporated by reference herein. Any conflict or contradiction betweena statement in the bodily text of this specification and a statement inany of the incorporated documents is to be resolved in favor of thestatement in the bodily text.

1. An apparatus for use in treating a hollow anatomical structure (HAS),the apparatus comprising: an elongate member having a distal section anda proximal section, the elongate member being sized for insertion into aHAS; a heating element located on the elongate member and having a firstlength; wherein the heating element has a distal section and a proximalsection and is configured to apply energy along a length of the HAS inconsecutive treatment segments of the HAS; a plurality of index markingsmarked on the elongate member; wherein the index markings are configuredto be movably indexed in a distal to proximal direction via movement ofthe elongate member in the distal to proximal direction to sequentiallyposition the heating element axially along the length of the HAS; atleast one final marking distinct from the index markings and marked onthe elongate member that indicates a final distance from said finalmarking to the proximal section of the heating element; and a warningsection marked on the elongate member, the warning section comprising adistinct marking different from the plurality of index markings and theat least one final marking; wherein consecutive index markings arespaced apart by a second length, the second length being less than thefirst length to ensure overlap of consecutive treated segments of theHAS when the heating element is moved in the distal to proximaldirection along the HAS.
 2. The apparatus of claim 1, wherein thewarning section is located on the elongate member proximal of the atleast one final marking.
 3. The apparatus of claim 1, wherein thewarning section is between the plurality of index markings and the atleast one final marking.
 4. The apparatus of claim 3, wherein thewarning section extends along the elongate member from one index markingto one final marking to form a prominent and highly visible section ofthe catheter.
 5. An apparatus for treating a hollow anatomical structure(HAS), the apparatus comprising: an elongate member having a distalsection and a proximal section; a heating element on the elongate memberand having a distal section and a proximal section; wherein the heatingelement has a first length; a plurality of index markings marked on theelongate member; wherein consecutive index markings are spaced apart bya second length, the second length being less than the first length toallow for overlap of consecutive treated segments of the HAS; at leastone final marking marked on the elongate member that is distinct fromthe index markings and spaced proximally from the proximal section ofthe heating element to indicate a final treatment position of theheating element; and a warning section marked on the elongate member,wherein the warning section comprises a distinct marking different fromthe plurality of index markings and the at least one final marking. 6.The apparatus of claim 5, wherein the warning section is located on theelongate member proximal of the at least one final marking.
 7. Theapparatus of claim 5, wherein the warning section is between theplurality of index markings and the at least one final marking.
 8. Theapparatus of claim 5, wherein the at least one final marking isconfigured for use with an introducer sheath such that the final markingindicates a final treatment position of the heating element relative tothe sheath, the final marking configured to become visible outside theintroducer sheath during pull-back of the elongate member, the finalmarking configured to indicate that further heating of the heatingelement after the final marking is visible may cause the heating elementto heat while it is at least partly within the introducer sheath.
 9. Theapparatus of claim 5, wherein the at least one final marking comprisesfirst and second final markings, the first final marking configured tospecify a longer introducer sheath for use with the elongate member andthe second final marking configured to specify a shorter introducersheath for use with the elongate member, each of the first and secondfinal markings allowing the heating element to avoid heating inside therespective specified introducer sheath.
 10. The apparatus of claim 9,wherein the first final marking is configured to specify the longerintroducer sheath by indicating the length of the longer introducersheath and the second final marking is configured to specify the shorterintroducer sheath by indicating the length of the shorter introducersheath.
 11. The apparatus of claim 10 wherein each respective finalmarking indicates the length of the longer and shorter introducersheaths numerically.
 12. The apparatus of claim 9, wherein: the firstfinal marking is marked on the catheter at a distance from thedistal-most end of the elongate member, the distance comprising at leastthe length of the heating element plus the length of the longerintroducer sheath; and the second final marking is marked on thecatheter at a distance from the distal-most end of the elongate member,the distance comprising at least the length of the heating element plusthe length of the shorter introducer sheath.
 13. The apparatus of claim5, wherein the index markings, the final marking, and the warningsection have visually distinct appearances.
 14. The apparatus of claim5, wherein the heating element comprises an electrically driven heatingelement, a resistive element, an electrode, a laser, a fluid-conductingheat exchanger, or a chemical reaction chamber.
 15. An apparatus fortreating a hollow anatomical structure (HAS), the apparatus comprising:an elongate member having a distal section and a proximal section; aheating element located on the elongate member and having a distalsection, a proximal section, and a first length; a plurality of indexmarkings marked on the elongate member, consecutive index markings beingspaced apart by a second length that is less than or approximately equalto the first length; at least one final marking distinct from the indexmarkings and marked on the elongate member to indicate a final distancefrom said final marking to the proximal section of the heating element;and a warning section marked on the elongate member, the warning sectioncomprising a distinct marking different from the plurality of indexmarkings and the at least one final marking.
 16. The apparatus of claim15, further comprising: an introducer sheath having a distal sheath tipconfigured for insertion into the HAS, a proximal sheath opening, and asheath length; the elongate member configured for insertion into the HASthrough the introducer sheath; and the plurality of index markingsconfigured to become visible sequentially outside the introducer sheathas the elongate member is pulled back between sequential heat treatmentsto the HAS.
 17. The system of claim 16, wherein the at least one finalmarking is configured to become visible outside the introducer sheathafter the plurality of index markings have already become visible and toindicate that heating after further pullback will occur with the heatingelement near or partly inside the introducer sheath.
 18. The apparatusof claim 15, wherein the warning section is located on the elongatemember proximal of the at least one final marking.
 19. The apparatus ofclaim 15, wherein the warning section is between the plurality of indexmarkings and the at least one final marking.
 20. The apparatus of claim15, further configured to provide simplified, procedure-specificguidance during a medical procedure, wherein the plurality of indexmarkings are preconfigured to correspond to effective treatment lengths,allowing the user to refer only to the markings on the elongate memberto perform an effective procedure.